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Timothy L. Comstock - One of the best experts on this subject based on the ideXlab platform.
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Besifloxacin ophthalmic suspension 0.6% in the treatment of Bacterial Conjunctivitis patients with Pseudomonas aeruginosa infections.
Clinical ophthalmology (Auckland N.Z.), 2012Co-Authors: Bruce E. Silverstein, Lynne S. Gearinger, Timothy W Morris, Heleen H Decory, Timothy L. ComstockAbstract:BACKGROUND The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of Bacterial Conjunctivitis infections due to Pseudomonas aeruginosa. METHODS We undertook a post hoc analysis of clinical outcomes in patients with Bacterial Conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included Bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular Bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and Bacterial eradication and clinical resolution rates integrated. RESULTS Of 1317 patients with culture-confirmed Bacterial Conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity. CONCLUSION The incidence of Bacterial Conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to Bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.
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Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children
Clinical drug investigation, 2012Co-Authors: Jesse Deleon, Timothy W Morris, Lynne S. Gearinger, Bruce E. Silverstein, Catherine Allaire, Kirk Bateman, Timothy L. ComstockAbstract:Background and Objective: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with Bacterial Conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of Bacterial Conjunctivitis.
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Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children
Clinical Drug Investigation, 2012Co-Authors: Jesse Deleon, Timothy W Morris, Lynne S. Gearinger, Bruce E. Silverstein, Catherine Allaire, Kirk M. Bateman, Timothy L. ComstockAbstract:Background and Objective: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with Bacterial Conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of Bacterial Conjunctivitis. Study Design: This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study. Methods: A total of 474 patients aged ≥1 year with Bacterial Conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7±1 (visit 3). The co-primary efficacy endpoints were Bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed Bacterial Conjunctivitis. Secondary efficacy endpoints were Bacterial eradication and clinical resolution at day 7±1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall Bacterial species and individual Gram- positive and Gram-negative Bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7±1. Results: Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p
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Safety and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% in the Treatment of Bacterial Conjunctivitis
Clinical Drug Investigation, 2010Co-Authors: Timothy L. Comstock, Heleen H Decory, Michael R. Paterno, Dale W. UsnerAbstract:Background: Besifloxacin is a novel fluoroquinolone, specifically a chlorofluoroquinolone, with potent broad-spectrum bactericidal activity for the topical treatment of Bacterial Conjunctivitis. Objective: The objective of this report was to provide a comprehensive assessment of the safety and tolerability of besifloxacin ophthalmic suspension 0.6% across clinical and phase I safety studies. Methods: Data were drawn from two phase I safety studies in healthy adults, an open-label, phase II pharmacokinetic study of patients with Bacterial Conjunctivitis and from integrated data from three randomized, double-masked, parallel-group, safety and efficacy studies of patients with Bacterial Conjunctivitis (two were vehicle controlled and one was active controlled with moxifloxacin ophthalmic solution 0.5%, as base). Safety assessments included changes in visual acuity, ocular assessments with ophthalmoscopy and biomicroscopy, and assessment of adverse events (AEs). Results: Safety data for besifloxacin ophthalmic suspension 0.6% were available for 1350 patients, including 1192 patients (1810 eyes) in the integrated analysis. Systemic exposure following topical administration of besifloxacin ophthalmic suspension 0.6% was negligible. No changes were seen in corneal endothelial cell density. In the integrated safety analysis of the three safety and efficacy studies, the most commonly reported ocular AEs in study eyes receiving besifloxacin ophthalmic suspension 0.6% were blurred vision (2.1 %), eye pain (1.8%), eye irritation (1.4%), nonspecific Conjunctivitis (1.2%) and eye pruritus (1.1%). Blurred vision, eye irritation and nonspecific Conjunctivitis occurred in significantly fewer besifloxacin-treated patients than in vehicle-treated patients (p≤0.05). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs were mild in severity and there were no treatment-related serious AEs. Besifloxacin ophthalmic suspension 0.6% did not significantly affect visual acuity, biomicroscopy or ophthalmoscopy compared with vehicle or moxifloxacin. Conclusion: The results from this comprehensive data set of 1350 patients demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety profile and is well tolerated.
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Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Children and Adolescents with Bacterial Conjunctivitis
Pediatric Drugs, 2010Co-Authors: Timothy L. Comstock, Dale W. Usner, Michael R. Paterno, Michael E. PichicheroAbstract:Background: Acute Conjunctivitis is the most frequent eye disorder seen by primary care physicians and one that often affects children. Besifloxacin is a new topical fluoroquinolone, the first chlorofluoroquinolone, for the treatment of Bacterial Conjunctivitis. Objective: To examine the efficacy and safety of besifloxacin ophthalmic suspension 0.6% in patients aged 1–17 years with Bacterial Conjunctivitis. Methods: This was a post hoc analysis of a subgroup of pediatric patients aged 1–17 years who had participated in three previously reported, randomized, double-masked, parallel-group, multicenter, clinical trials evaluating the safety and efficacy of besifloxacin in the treatment of Bacterial Conjunctivitis. The studies were conducted in a community setting (clinical centers). All three clinical trials included children (aged ≥1 year) with a clinical diagnosis of Bacterial Conjunctivitis in at least one eye, based on the presence at baseline of grade 1 or greater purulent conjunctival discharge and conjunctival injection, and pin-hole visual acuity of at least 20/200 in both eyes for verbal patients. Two trials were vehicle controlled; the third trial was comparator controlled (moxifloxacin hydrochloride ophthalmic solution 0.5% as base). In all studies, besifloxacin ophthalmic suspension 0.6% was administered as one drop in the affected eye(s) three times daily, at approximately 6-hourly intervals, for 5 days. The main outcome measures were clinical resolution and microbial eradication at visit 2 (day 4 ± 1 in one study; day 5 ± 1 in the other two studies) and visit 3 (day 8 or 9). Data from the two vehicle-controlled studies were combined for the assessments to provide greater statistical power. Results: This analysis included 815 pediatric patients aged 1–17 years (447 with culture-confirmed Bacterial Conjunctivitis). Clinical resolution was significantly greater (p < 0.05) in the besifloxacin group than in the vehicle group at both visit 2 (53.7% vs 41.3%) and visit 3 (88.1% vs 73.0%). Similarly, microbial eradication was significantly higher with besifloxacin than with vehicle at visit 2 (85.8% vs 56.3%) and visit 3 (82.8% vs 68.3%). No significant differences in clinical resolution and microbial eradication were noted between besifloxacin and moxifloxacin. Besifloxacin was well tolerated, with similar incidences of adverse events in the besifloxacin, vehicle, and moxifloxacin groups. Conclusion: Besifloxacin ophthalmic suspension 0.6% was shown to be safe and effective for the treatment of Bacterial Conjunctivitis in children and adolescents aged 1–17 years.
Brian Hurwitz - One of the best experts on this subject based on the ideXlab platform.
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antibiotics versus placebo for acute Bacterial Conjunctivitis
Cochrane Database of Systematic Reviews, 2012Co-Authors: Aziz Sheikh, Brian Hurwitz, Constant P Van Schayck, Susannah Mclean, Ulugbek NurmatovAbstract:Background Acute Bacterial Conjunctivitis is an infection of the conjunctiva. Both the palpebral and the bulbar ocular conjunctival surfaces are usually affected and typically become red and inflamed. Antibiotic therapy is widely used for the treatment of acute Bacterial Conjunctivitis. This Cochrane Review was first published in The Cochrane Library in 1999; updated in 2006 and again in 2012. Objectives To assess the benefits and harms of antibiotic therapy in the management of acute Bacterial Conjunctivitis. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), MEDLINE (January 1950 to July 2012), EMBASE (January 1980 to July 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 18 July 2012. Selection criteria We included double-masked randomised controlled trials (RCTs) in which any form of antibiotic treatment had been compared with placebo/vehicle in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. Data collection and analysis Two authors (UN and SM) independently checked and reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies. We graded the included RCTs for methodological quality using Cochrane methodology. We performed data extraction in a standardised manner. We performed random-effects meta-analyses using RevMan. Main results We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality. Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence. Authors' conclusions Although acute Bacterial Conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection.
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The Cochrane Library - Antibiotics versus placebo for acute Bacterial Conjunctivitis.
The Cochrane database of systematic reviews, 2012Co-Authors: Aziz Sheikh, Brian Hurwitz, Constant P Van Schayck, Susannah Mclean, Ulugbek NurmatovAbstract:Background Acute Bacterial Conjunctivitis is an infection of the conjunctiva. Both the palpebral and the bulbar ocular conjunctival surfaces are usually affected and typically become red and inflamed. Antibiotic therapy is widely used for the treatment of acute Bacterial Conjunctivitis. This Cochrane Review was first published in The Cochrane Library in 1999; updated in 2006 and again in 2012. Objectives To assess the benefits and harms of antibiotic therapy in the management of acute Bacterial Conjunctivitis. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), MEDLINE (January 1950 to July 2012), EMBASE (January 1980 to July 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 18 July 2012. Selection criteria We included double-masked randomised controlled trials (RCTs) in which any form of antibiotic treatment had been compared with placebo/vehicle in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. Data collection and analysis Two authors (UN and SM) independently checked and reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies. We graded the included RCTs for methodological quality using Cochrane methodology. We performed data extraction in a standardised manner. We performed random-effects meta-analyses using RevMan. Main results We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality. Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence. Authors' conclusions Although acute Bacterial Conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection.
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Antibiotics versus placebo for acute Bacterial Conjunctivitis.
The Cochrane database of systematic reviews, 2006Co-Authors: Aziz Sheikh, Brian HurwitzAbstract:There are concerns about whether antibiotic therapy confers significant clinical benefit in the treatment of acute Bacterial Conjunctivitis. The aim of this review was to assess the benefit and harm of antibiotic therapy in the management of acute Bacterial Conjunctivitis. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register), MEDLINE, EMBASE, SIGLE, NRR, PubMed and the reference lists of identified trial reports. We used the Science Citation Index to look for articles that cited the relevant studies, and we contacted investigators and pharmaceutical companies for information about additional trials. We included double masked randomised controlled trials in which any form of antibiotic treatment had been compared with placebo in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. One author extracted data and the accuracy was checked by a second author. This review includes five trials which randomised a total of 1034 participants. One further trial is currently 'awaiting assessment'. This has been published in abstract form and has yet to be fully reported. Three of the trials have been conducted on a selected specialist care patient population and the two more recent trials have been conducted in a community care setting. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. Meta-analyses of data on clinical and microbiological remission rates reveal that topical antibiotics are of benefit in improving early (days 2 to 5) clinical (RR 1.24, 95% CI 1.05 to 1.45) and microbiological (RR 1.77, 95% CI 1.23 to 2.54) remission rates; later (days 6 to 10) data reveal that these early advantages in clinical (RR 1.11, 95% CI 1.02 to 1.21) and microbiological cure rates are reduced (RR 1.56, 95% CI 1.17 to 2.09), but persist. Most cases however resolve spontaneously with clinical remission being achieved in 65% (95% CI 59 to 70) by days 2 to 5 in those receiving placebo. No serious outcomes were reported in either the active or placebo arms of these trials, indicating that important sight-threatening complications are an infrequent occurrence. Acute Bacterial Conjunctivitis is frequently a self-limiting condition, but the use of antibiotics is associated with significantly improved rates of clinical and microbiological remission.
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topical antibiotics for acute Bacterial Conjunctivitis cochrane systematic review and meta analysis update
British Journal of General Practice, 2005Co-Authors: Aziz Sheikh, Brian HurwitzAbstract:Background Uncertainty remains about the extent to which findings from our previously published systematic review and meta-analysis of double-blind, randomised controlled trials of topical antibiotics compared with placebo in the management of patients with acute Bacterial Conjunctivitis treated in secondary care outpatient settings are generalisable to the management of the condition in primary care settings. We updated our review, undertaking searches, methodological assessment, data extraction and analysis according to a pre-defined protocol. In addition to the previous three included studies, we identified two additional double-blind primary care trials, one which compares fusidic acid gel with placebo gel and one which compares chloramphenicol eye drops with placebo eye drops in children. Meta-analyses of clinical and microbiological remission data reveal that topical antibiotics are of benefit in improving early (days 2–5) clinical (relative risk [RR] = 1.24, 95% confidence interval [CI] = 1.05 to 1.45) and microbiological (RR = 1.77, 95% CI = 1.23 to 2.54) remission rates; later (days 6–10) data reveal that these early advantages in clinical (RR = 1.11, 95% CI = 1.02 to 1.21) and microbiological cure rates are reduced (RR 1.56, 95% CI = 1.17 to 2.09), but persist. Most cases of acute Bacterial Conjunctivitis resolve spontaneously. While topical antibiotics are associated with significantly improved rates of early (days 2–5) clinical remission, this benefit is marginal for later remission (days 6–10).
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topical antibiotics for acute Bacterial Conjunctivitis a systematic review
British Journal of General Practice, 2001Co-Authors: Aziz Sheikh, Brian HurwitzAbstract:There has been uncertainty about whether antibiotic therapy confers significant benefit in the treatment of acute Bacterial Conjunctivitis. This study aimed to assess the efficacy of antibiotic therapy in the management of acute Bacterial Conjunctivitis. Using standard Cochrane search methods, we identified double-blind randomised controlled trials in which any form of antibiotic treatment (topical, systemic or combination) had been compared with placebo in the management of acute Bacterial Conjunctivitis. Data extraction and analysis followed a pre-defined protocol. Meta-analysis was performed to obtain summary measures of relative risk. Six published trials were identified, of which three fulfilled the eligibility criteria for inclusion in this review. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. Meta-analysis indicates that acute Bacterial Conjunctivitis is frequently a self-limiting condition, as clinical remission occurred by days 2 to 5 in 64% (95% confidence interval (CI) = 57-71) of those treated with placebo. Treatment with antibiotics was, however, associated with significantly better rates of clinical remission (days 2 to 5: relative risk (RR) = 1.31, 95% CI = 1.11-1.55), with a suggestion that this benefit was maintained for late clinical remission (days 6 to 10: RR = 1.27, 95% CI = 1.00-1.61). Acute Bacterial Conjunctivitis is frequently a self-limiting condition but the use of antibiotics is associated with significantly improved rates of early clinical remission, and early and late microbiological remission. Since trials to date have been conducted in selected specialist care patient populations, generalisation of these results to a primary care-based population should be undertaken with a degree of caution.
Aziz Sheikh - One of the best experts on this subject based on the ideXlab platform.
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antibiotics versus placebo for acute Bacterial Conjunctivitis
Cochrane Database of Systematic Reviews, 2012Co-Authors: Aziz Sheikh, Brian Hurwitz, Constant P Van Schayck, Susannah Mclean, Ulugbek NurmatovAbstract:Background Acute Bacterial Conjunctivitis is an infection of the conjunctiva. Both the palpebral and the bulbar ocular conjunctival surfaces are usually affected and typically become red and inflamed. Antibiotic therapy is widely used for the treatment of acute Bacterial Conjunctivitis. This Cochrane Review was first published in The Cochrane Library in 1999; updated in 2006 and again in 2012. Objectives To assess the benefits and harms of antibiotic therapy in the management of acute Bacterial Conjunctivitis. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), MEDLINE (January 1950 to July 2012), EMBASE (January 1980 to July 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 18 July 2012. Selection criteria We included double-masked randomised controlled trials (RCTs) in which any form of antibiotic treatment had been compared with placebo/vehicle in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. Data collection and analysis Two authors (UN and SM) independently checked and reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies. We graded the included RCTs for methodological quality using Cochrane methodology. We performed data extraction in a standardised manner. We performed random-effects meta-analyses using RevMan. Main results We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality. Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence. Authors' conclusions Although acute Bacterial Conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection.
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The Cochrane Library - Antibiotics versus placebo for acute Bacterial Conjunctivitis.
The Cochrane database of systematic reviews, 2012Co-Authors: Aziz Sheikh, Brian Hurwitz, Constant P Van Schayck, Susannah Mclean, Ulugbek NurmatovAbstract:Background Acute Bacterial Conjunctivitis is an infection of the conjunctiva. Both the palpebral and the bulbar ocular conjunctival surfaces are usually affected and typically become red and inflamed. Antibiotic therapy is widely used for the treatment of acute Bacterial Conjunctivitis. This Cochrane Review was first published in The Cochrane Library in 1999; updated in 2006 and again in 2012. Objectives To assess the benefits and harms of antibiotic therapy in the management of acute Bacterial Conjunctivitis. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), MEDLINE (January 1950 to July 2012), EMBASE (January 1980 to July 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 18 July 2012. Selection criteria We included double-masked randomised controlled trials (RCTs) in which any form of antibiotic treatment had been compared with placebo/vehicle in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. Data collection and analysis Two authors (UN and SM) independently checked and reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies. We graded the included RCTs for methodological quality using Cochrane methodology. We performed data extraction in a standardised manner. We performed random-effects meta-analyses using RevMan. Main results We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality. Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence. Authors' conclusions Although acute Bacterial Conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection.
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Effectiveness, tolerability and safety of azithromycin 1% in DuraSite for acute Bacterial Conjunctivitis.
Patient preference and adherence, 2010Co-Authors: Susannah Mclean, Aziz SheikhAbstract:® ". These searches of published literature were supplemented with searches for unpublished trials and trials in progress. Results: We found six reports of randomized controlled trials investigating the role of azithromycin 1% in DuraSite ® for the management of acute Bacterial Conjunctivitis. The quality of these trials was judged to be moderate to high. These trials assessed effectiveness, tolerability and safety outcomes, but we found no trials looking at cost-effectiveness. DuraSite ® is a relatively stable formulation and so azithromycin 1% in DuraSite ® has a simpler dosing schedule than other available topical antibiotics. It appears to be similar to other topical antibiotics in its effectiveness, but minor side effects are quite common. Conclusion: Acute Bacterial Conjunctivitis is a relatively mild, typically self-limiting, infection. Antibiotics should seldom be required. If, however, a decision to prescribe antibiotics is made, azithromycin 1% in DuraSite ® is likely to be broadly comparable in its effectiveness to most other antibiotics used to treat acute Bacterial Conjunctivitis. Further research is needed to determine its cost-effectiveness.
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Antibiotics versus placebo for acute Bacterial Conjunctivitis.
The Cochrane database of systematic reviews, 2006Co-Authors: Aziz Sheikh, Brian HurwitzAbstract:There are concerns about whether antibiotic therapy confers significant clinical benefit in the treatment of acute Bacterial Conjunctivitis. The aim of this review was to assess the benefit and harm of antibiotic therapy in the management of acute Bacterial Conjunctivitis. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register), MEDLINE, EMBASE, SIGLE, NRR, PubMed and the reference lists of identified trial reports. We used the Science Citation Index to look for articles that cited the relevant studies, and we contacted investigators and pharmaceutical companies for information about additional trials. We included double masked randomised controlled trials in which any form of antibiotic treatment had been compared with placebo in the management of acute Bacterial Conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments. One author extracted data and the accuracy was checked by a second author. This review includes five trials which randomised a total of 1034 participants. One further trial is currently 'awaiting assessment'. This has been published in abstract form and has yet to be fully reported. Three of the trials have been conducted on a selected specialist care patient population and the two more recent trials have been conducted in a community care setting. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. Meta-analyses of data on clinical and microbiological remission rates reveal that topical antibiotics are of benefit in improving early (days 2 to 5) clinical (RR 1.24, 95% CI 1.05 to 1.45) and microbiological (RR 1.77, 95% CI 1.23 to 2.54) remission rates; later (days 6 to 10) data reveal that these early advantages in clinical (RR 1.11, 95% CI 1.02 to 1.21) and microbiological cure rates are reduced (RR 1.56, 95% CI 1.17 to 2.09), but persist. Most cases however resolve spontaneously with clinical remission being achieved in 65% (95% CI 59 to 70) by days 2 to 5 in those receiving placebo. No serious outcomes were reported in either the active or placebo arms of these trials, indicating that important sight-threatening complications are an infrequent occurrence. Acute Bacterial Conjunctivitis is frequently a self-limiting condition, but the use of antibiotics is associated with significantly improved rates of clinical and microbiological remission.
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topical antibiotics for acute Bacterial Conjunctivitis cochrane systematic review and meta analysis update
British Journal of General Practice, 2005Co-Authors: Aziz Sheikh, Brian HurwitzAbstract:Background Uncertainty remains about the extent to which findings from our previously published systematic review and meta-analysis of double-blind, randomised controlled trials of topical antibiotics compared with placebo in the management of patients with acute Bacterial Conjunctivitis treated in secondary care outpatient settings are generalisable to the management of the condition in primary care settings. We updated our review, undertaking searches, methodological assessment, data extraction and analysis according to a pre-defined protocol. In addition to the previous three included studies, we identified two additional double-blind primary care trials, one which compares fusidic acid gel with placebo gel and one which compares chloramphenicol eye drops with placebo eye drops in children. Meta-analyses of clinical and microbiological remission data reveal that topical antibiotics are of benefit in improving early (days 2–5) clinical (relative risk [RR] = 1.24, 95% confidence interval [CI] = 1.05 to 1.45) and microbiological (RR = 1.77, 95% CI = 1.23 to 2.54) remission rates; later (days 6–10) data reveal that these early advantages in clinical (RR = 1.11, 95% CI = 1.02 to 1.21) and microbiological cure rates are reduced (RR 1.56, 95% CI = 1.17 to 2.09), but persist. Most cases of acute Bacterial Conjunctivitis resolve spontaneously. While topical antibiotics are associated with significantly improved rates of early (days 2–5) clinical remission, this benefit is marginal for later remission (days 6–10).
Dale W. Usner - One of the best experts on this subject based on the ideXlab platform.
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Integrated analysis of three Bacterial Conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: etiology of Bacterial Conjunctivitis and antiBacterial susceptibility profile.
Clinical ophthalmology (Auckland N.Z.), 2011Co-Authors: Wolfgang Haas, Lynne S. Gearinger, Dale W. Usner, Heleen H Decory, Timothy W MorrisAbstract:Background The purpose of this paper is to report on the Bacterial species isolated from patients with Bacterial Conjunctivitis participating in three clinical trials of besifloxacin ophthalmic suspension, 0.6%, and their in vitro antiBacterial susceptibility profiles.
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Safety and Tolerability of Besifloxacin Ophthalmic Suspension 0.6% in the Treatment of Bacterial Conjunctivitis
Clinical Drug Investigation, 2010Co-Authors: Timothy L. Comstock, Heleen H Decory, Michael R. Paterno, Dale W. UsnerAbstract:Background: Besifloxacin is a novel fluoroquinolone, specifically a chlorofluoroquinolone, with potent broad-spectrum bactericidal activity for the topical treatment of Bacterial Conjunctivitis. Objective: The objective of this report was to provide a comprehensive assessment of the safety and tolerability of besifloxacin ophthalmic suspension 0.6% across clinical and phase I safety studies. Methods: Data were drawn from two phase I safety studies in healthy adults, an open-label, phase II pharmacokinetic study of patients with Bacterial Conjunctivitis and from integrated data from three randomized, double-masked, parallel-group, safety and efficacy studies of patients with Bacterial Conjunctivitis (two were vehicle controlled and one was active controlled with moxifloxacin ophthalmic solution 0.5%, as base). Safety assessments included changes in visual acuity, ocular assessments with ophthalmoscopy and biomicroscopy, and assessment of adverse events (AEs). Results: Safety data for besifloxacin ophthalmic suspension 0.6% were available for 1350 patients, including 1192 patients (1810 eyes) in the integrated analysis. Systemic exposure following topical administration of besifloxacin ophthalmic suspension 0.6% was negligible. No changes were seen in corneal endothelial cell density. In the integrated safety analysis of the three safety and efficacy studies, the most commonly reported ocular AEs in study eyes receiving besifloxacin ophthalmic suspension 0.6% were blurred vision (2.1 %), eye pain (1.8%), eye irritation (1.4%), nonspecific Conjunctivitis (1.2%) and eye pruritus (1.1%). Blurred vision, eye irritation and nonspecific Conjunctivitis occurred in significantly fewer besifloxacin-treated patients than in vehicle-treated patients (p≤0.05). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs were mild in severity and there were no treatment-related serious AEs. Besifloxacin ophthalmic suspension 0.6% did not significantly affect visual acuity, biomicroscopy or ophthalmoscopy compared with vehicle or moxifloxacin. Conclusion: The results from this comprehensive data set of 1350 patients demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety profile and is well tolerated.
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Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Children and Adolescents with Bacterial Conjunctivitis
Pediatric Drugs, 2010Co-Authors: Timothy L. Comstock, Dale W. Usner, Michael R. Paterno, Michael E. PichicheroAbstract:Background: Acute Conjunctivitis is the most frequent eye disorder seen by primary care physicians and one that often affects children. Besifloxacin is a new topical fluoroquinolone, the first chlorofluoroquinolone, for the treatment of Bacterial Conjunctivitis. Objective: To examine the efficacy and safety of besifloxacin ophthalmic suspension 0.6% in patients aged 1–17 years with Bacterial Conjunctivitis. Methods: This was a post hoc analysis of a subgroup of pediatric patients aged 1–17 years who had participated in three previously reported, randomized, double-masked, parallel-group, multicenter, clinical trials evaluating the safety and efficacy of besifloxacin in the treatment of Bacterial Conjunctivitis. The studies were conducted in a community setting (clinical centers). All three clinical trials included children (aged ≥1 year) with a clinical diagnosis of Bacterial Conjunctivitis in at least one eye, based on the presence at baseline of grade 1 or greater purulent conjunctival discharge and conjunctival injection, and pin-hole visual acuity of at least 20/200 in both eyes for verbal patients. Two trials were vehicle controlled; the third trial was comparator controlled (moxifloxacin hydrochloride ophthalmic solution 0.5% as base). In all studies, besifloxacin ophthalmic suspension 0.6% was administered as one drop in the affected eye(s) three times daily, at approximately 6-hourly intervals, for 5 days. The main outcome measures were clinical resolution and microbial eradication at visit 2 (day 4 ± 1 in one study; day 5 ± 1 in the other two studies) and visit 3 (day 8 or 9). Data from the two vehicle-controlled studies were combined for the assessments to provide greater statistical power. Results: This analysis included 815 pediatric patients aged 1–17 years (447 with culture-confirmed Bacterial Conjunctivitis). Clinical resolution was significantly greater (p < 0.05) in the besifloxacin group than in the vehicle group at both visit 2 (53.7% vs 41.3%) and visit 3 (88.1% vs 73.0%). Similarly, microbial eradication was significantly higher with besifloxacin than with vehicle at visit 2 (85.8% vs 56.3%) and visit 3 (82.8% vs 68.3%). No significant differences in clinical resolution and microbial eradication were noted between besifloxacin and moxifloxacin. Besifloxacin was well tolerated, with similar incidences of adverse events in the besifloxacin, vehicle, and moxifloxacin groups. Conclusion: Besifloxacin ophthalmic suspension 0.6% was shown to be safe and effective for the treatment of Bacterial Conjunctivitis in children and adolescents aged 1–17 years.
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Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Children and Adolescents with Bacterial Conjunctivitis
Paediatric drugs, 2010Co-Authors: Timothy L. Comstock, Dale W. Usner, Michael R. Paterno, Michael E. PichicheroAbstract:Background: Acute Conjunctivitis is the most frequent eye disorder seen by primary care physicians and one that often affects children. Besifloxacin is a new topical fluoroquinolone, the first chlorofluoroquinolone, for the treatment of Bacterial Conjunctivitis.
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efficacy and safety of besifloxacin ophthalmic suspension 0 6 compared with moxifloxacin ophthalmic solution 0 5 for treating Bacterial Conjunctivitis
Ophthalmology, 2009Co-Authors: Marguerite B Mcdonald, Timothy L. Comstock, Timothy W Morris, Wolfgang Haas, Michael R. Paterno, Eugene E Protzko, Lynne Brunner, Dale W. UsnerAbstract:Objective To compare the clinical and antimicrobial efficacy of besifloxacin ophthalmic suspension 0.6% with that of moxifloxacin ophthalmic solution 0.5% for the treatment of Bacterial Conjunctivitis. Design Multicenter, randomized, double-masked, parallel-group, active-controlled, noninferiority study. Participants Patients 1 year of age or older with clinical manifestations of Bacterial Conjunctivitis. Methods Eligible patients were randomized to either besifloxacin suspension or moxifloxacin solution, instilled in the infected eye(s) 3 times daily for 5 days, and participated in study visits on days 1, 5 (±1 day), and 8 (+1 day). Assessments included clinical evaluation of signs and symptoms, visual acuity, biomicroscopy, and culture of the infected eye(s) at each visit, as well as direct ophthalmoscopy on days 1 and 8. Main Outcome Measures The primary efficacy end points were clinical resolution and microbial eradication of baseline Bacterial infection on day 5 in patients with culture-confirmed Bacterial Conjunctivitis. Secondary end points included clinical resolution and microbial eradication on day 8, individual clinical outcomes, microbial and clinical outcomes by Bacterial species, and safety. Results A total of 1161 patients (533 with culture-confirmed Bacterial Conjunctivitis) were randomized. Based on the 95% confidence interval (CI) of the difference, besifloxacin was noninferior to moxifloxacin for clinical resolution on day 5 (58.3% vs. 59.4%, respectively; 95% CI, –9.48 to 7.29) and day 8 (84.5% vs. 84.0%, respectively, 95% CI, –5.6% to 6.75%) and for microbial eradication on day 5 (93.3% vs. 91.1%, respectively, 95% CI, –2.44 to 6.74) and day 8 (87.3% vs. 84.7%; 95% CI, –3.32 to 8.53). There was no statistically significant difference between the 2 treatment groups for either efficacy end points on days 5 or 8 ( P >0.05). Besifloxacin and moxifloxacin were well tolerated. The cumulative frequency of ocular adverse events was similar between treatments (12% and 14% with besifloxacin and moxifloxacin, respectively). However, eye irritation occurred more often in moxifloxacin-treated eyes (0.3% for besifloxacin vs. 1.4% for moxifloxacin; P = 0.0201). Conclusions Besifloxacin ophthalmic suspension was non inferior to moxifloxacin ophthalmic suspension and provided similar safety and efficacy (clinical and microbiological) outcomes when used for the treatment of Bacterial Conjunctivitis. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
Timothy W Morris - One of the best experts on this subject based on the ideXlab platform.
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Besifloxacin ophthalmic suspension 0.6% in the treatment of Bacterial Conjunctivitis patients with Pseudomonas aeruginosa infections.
Clinical ophthalmology (Auckland N.Z.), 2012Co-Authors: Bruce E. Silverstein, Lynne S. Gearinger, Timothy W Morris, Heleen H Decory, Timothy L. ComstockAbstract:BACKGROUND The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of Bacterial Conjunctivitis infections due to Pseudomonas aeruginosa. METHODS We undertook a post hoc analysis of clinical outcomes in patients with Bacterial Conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included Bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular Bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and Bacterial eradication and clinical resolution rates integrated. RESULTS Of 1317 patients with culture-confirmed Bacterial Conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity. CONCLUSION The incidence of Bacterial Conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to Bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.
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Microbiological etiology and susceptibility of Bacterial Conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin.
Advances in therapy, 2012Co-Authors: Wolfgang Haas, Lynne S. Gearinger, Christine K. Hesje, Christine M. Sanfilippo, Timothy W MorrisAbstract:Introduction Bacterial Conjunctivitis is a contagious infection of the surface of the eye usually treated empirically with topical antibiotics. Since the etiologic agent is rarely identified, it is important to monitor which bacteria cause Conjunctivitis and determine their antiBacterial resistance profiles.
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Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children
Clinical drug investigation, 2012Co-Authors: Jesse Deleon, Timothy W Morris, Lynne S. Gearinger, Bruce E. Silverstein, Catherine Allaire, Kirk Bateman, Timothy L. ComstockAbstract:Background and Objective: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with Bacterial Conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of Bacterial Conjunctivitis.
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Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children
Clinical Drug Investigation, 2012Co-Authors: Jesse Deleon, Timothy W Morris, Lynne S. Gearinger, Bruce E. Silverstein, Catherine Allaire, Kirk M. Bateman, Timothy L. ComstockAbstract:Background and Objective: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with Bacterial Conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of Bacterial Conjunctivitis. Study Design: This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study. Methods: A total of 474 patients aged ≥1 year with Bacterial Conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7±1 (visit 3). The co-primary efficacy endpoints were Bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed Bacterial Conjunctivitis. Secondary efficacy endpoints were Bacterial eradication and clinical resolution at day 7±1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall Bacterial species and individual Gram- positive and Gram-negative Bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7±1. Results: Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p
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High proportion of nontypeable Streptococcus pneumoniae isolates among sporadic, nonoutbreak cases of Bacterial Conjunctivitis.
Current eye research, 2011Co-Authors: Wolfgang Haas, Christine K. Hesje, Christine M. Sanfilippo, Timothy W MorrisAbstract:Purpose: Outbreaks of Bacterial Conjunctivitis have been linked to nontypeable strains of Streptococcus pneumoniae that lack a capsule, a key virulence factor for invasive infections. In contrast, ...