The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
John Howes - One of the best experts on this subject based on the ideXlab platform.
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double masked placebo controlled evaluation of Loteprednol etabonate 0 5 for postoperative inflammation
Journal of Cataract and Refractive Surgery, 1998Co-Authors: Robert H Stewart, John Howes, Gary D Novack, Barry Horwitz, Kathryn HartAbstract:Abstract Purpose: To compare the efficacy and safety of Loteprednol etabonate 0.5% with those of a placebo (vehicle) in controlling anterior chamber cell and flare reaction in patients having cataract surgery with intraocular lens (IOL) implantation. Methods: This randomized, double-masked, placebo-controlled, parallel-group multicenter study comprised patients who exhibited a minimum anterior chamber inflammation (ACI) score (sum of cell and flare reaction) of 3 (0 to 9 scale) on the day after cataract removal with posterior chamber IOL implantation. All 227 patients received Loteprednol etabonate 0.5% or the placebo 4 times a day in the operated eye for up to 14 days after surgery. Five patients without valid ontreatment follow-up visits were not evaluated for efficacy. Results: By the final visit, the ACI had resolved in 64% (70/109) of patients in the Loteprednol etabonate group and 29% (33/113) of those in the placebo group ( P P Conclusion: Loteprednol etabonate 0.5% led to a clinically meaningful reduction in the signs and symptoms of postoperative ACI and had an acceptable safety profile when compared with a placebo.
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a randomized double masked placebo controlled parallel study of 0 2 Loteprednol etabonate in patients with seasonal allergic conjunctivitis
The Journal of Allergy and Clinical Immunology, 1998Co-Authors: Steven J Dell, George M Lowry, James A Northcutt, John Howes, Gary D Novack, Kathryn HartAbstract:Abstract Background: Loteprednol etabonate is a site-active corticosteroid with efficacy and safety in treating ocular inflammation at the 0.5% concentration. Evidence from dose-response studies suggested that the 0.2% concentration might be effective in treating ocular allergy. Objectives: The objective of this study was to evaluate the effects of 0.2% Loteprednol etabonate in reducing the signs and symptoms of seasonal allergic conjunctivitis. Methods: This was a randomized, double-masked, placebo-controlled, parallel-group multicenter study. Patients with signs and symptoms of environmental seasonal allergic conjunctivitis received either Loteprednol etabonate or placebo bilaterally four times daily for 42 days. Results: Enrolled were 133 patients (66 receiving Loteprednol etabonate; 67 receiving placebo). A reduction in severity was seen in both Loteprednol etabonate and placebo groups for bulbar conjunctival injection (1.3 vs 0.9 units on a 0 to 3 scale) and itching (3.5 vs 3.1 units on a 0 to 4 scale) over the first 2 weeks. The treatment effect was –0.5 and –0.6 units in favor of Loteprednol etabonate ( P Conclusions: Loteprenol etabonate (0.2%) was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate (0.2%) had a safety profile comparable to placebo during this 6-week trial. (J Allergy Clin Immunol 1998;102:251-5.)
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failure to detect systemic levels and effects of Loteprednol etabonate and its metabolite pj 91 following chronic ocular administration
Journal of Ocular Pharmacology and Therapeutics, 1998Co-Authors: John Howes, Gary D NovackAbstract:The objective of this study was to determine the systemic exposure to Loteprednol etabonate (LE) following its chronic, ocular instillation. This was a randomized, double-masked, placebo controlled, single center trial in 14 normal volunteers. Subjects were randomly assigned to receive either LE (n=10) or placebo (n=4) and instructed to instill one drop into each eye 8 times daily on Days 0 and 1 and four times daily on Days 2 through 42. Blood levels of Loteprednol etabonate (LE) and its major metabolite PJ-91 (delta1 cortienic acid etabonate) in plasma, and circulating plasma cortisol levels were measured during the study. Plasma levels of LE or PJ-91 were below the level of quantitation (1 ng/mL) for all subjects in both treatment groups. Plasma cortisol levels were all within the normal range. Chronic exposure to LE at a concentration and frequency equal to or greater than the intended therapeutic dose does not result in detectable systemic levels or hypothalamic pituitary axis suppression.
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a controlled evaluation of the efficacy and safety of Loteprednol etabonate in the prophylactic treatment of seasonal allergic conjunctivitis
American Journal of Ophthalmology, 1997Co-Authors: Steven J Dell, George M Lowry, David G Shulman, John HowesAbstract:Purpose To evaluate the efficacy and safety of Loteprednol etabonate 0.5% as prophylactic treatment for the ocular signs and symptoms of seasonal allergic conjunctivitis. Methods In this randomized, double-masked, placebo-controlled, parallel study, 293 adults with history of seasonal allergic conjunctivitis were treated with either Loteprednol etabonate or vehicle (placebo) four times daily, beginning before the onset of the allergy season and continuing for 6 weeks. The primary efficacy measure was a primary composite score (sum of itching and bulbar conjunctival injection scores). Supportive efficacy measures were the investigator global assessment and a secondary composite score (sum of tearing, erythema, chemosis, and discomfort scores), all calculated during the 21-day peak pollen season. Results The proportion of patients who never developed moderate or severe signs and symptoms of allergy during the peak pollen season in the Loteprednol etabonate treatment group was greater than that in the placebo group. For the primary composite score, this efficacy criterion was reached by 94% of patients (136/145) in the Loteprednol etabonate group and 78% of patients (111/143) in the placebo group ( P = .001). The magnitude of effect was similar for the investigator global assessment (86% [118/138] vs 64% [87/137]; P P = .092). None of the Loteprednol etabonate-treated patients had an intraocular pressure increase of 10 mm Hg or more, whereas two placebo patients did. Conclusions Loteprednol etabonate is generally effective in prophylaxis of seasonal allergic conjunctivitis and has an acceptable safety profile.
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a double masked placebo controlled evaluation of the efficacy and safety of Loteprednol etabonate in the treatment of giant papillary conjunctivitis
American Journal of Ophthalmology, 1997Co-Authors: Mitchell H Friedlaender, John HowesAbstract:Purpose To evaluate the safety and effectiveness of Loteprednol etabonate 0.5% ophthalmic suspension in reducing the ocular signs and symptoms accompanying contact lens-associated giant papillary conjunctivitis. Methods In a randomized, double-masked, placebo-controlled, parallel-group study conducted at 14 academic or private practice clinics, 223 adults with contact lens-associated giant papillary conjunctivitis received either Loteprednol or the Loteprednol vehicle (placebo), one drop, four times daily for 6 weeks. Papillae, itching, contact lens intolerance, other signs and symptoms of giant papillary conjunctivitis (0-to-3 or 0-to-4 grade scales), and intraocular pressure were measured. Results The proportion of patients treated with Loteprednol who at final visit demonstrated an improvement in papillae of at least one grade (78%, 85/109) was significantly greater than the proportion of those treated with placebo (51%, 56/110; P = .001). A treatment difference favoring Loteprednol was seen with improvement in itching (95% vs 81%, 104/109 vs 89/110; P P = .053). Eight of 109 patients (7%, all taking Loteprednol) had an intraocular pressure increase of 10 mm Hg or more on at least one visit during treatment. After discontinuation of Loteprednol, intraocular pressure returned to normal levels. Both treatments were well tolerated, and no serious unexpected treatment-related medical events were reported. Conclusions The rapid therapeutic response combined with the low incidence and transient nature of any intraocular pressure increase suggests that Loteprednol is an appropriate treatment for giant papillary conjunctivitis.
Kathryn Hart - One of the best experts on this subject based on the ideXlab platform.
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a randomized double masked placebo controlled parallel study of Loteprednol etabonate 0 2 in patients with seasonal allergic conjunctivitis
Ophthalmology, 1999Co-Authors: David G Shulman, Gary D Novack, Larry L Lothringer, Jay M Rubin, Richard B Briggs, John F Howes, Kathryn HartAbstract:Abstract Objective To evaluate the effects of Loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis. Design Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration. Participants A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated. Intervention All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days. Main outcome measures Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured. Results A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE ( P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively). Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment. Conclusions Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.
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double masked placebo controlled evaluation of Loteprednol etabonate 0 5 for postoperative inflammation
Journal of Cataract and Refractive Surgery, 1998Co-Authors: Robert H Stewart, John Howes, Gary D Novack, Barry Horwitz, Kathryn HartAbstract:Abstract Purpose: To compare the efficacy and safety of Loteprednol etabonate 0.5% with those of a placebo (vehicle) in controlling anterior chamber cell and flare reaction in patients having cataract surgery with intraocular lens (IOL) implantation. Methods: This randomized, double-masked, placebo-controlled, parallel-group multicenter study comprised patients who exhibited a minimum anterior chamber inflammation (ACI) score (sum of cell and flare reaction) of 3 (0 to 9 scale) on the day after cataract removal with posterior chamber IOL implantation. All 227 patients received Loteprednol etabonate 0.5% or the placebo 4 times a day in the operated eye for up to 14 days after surgery. Five patients without valid ontreatment follow-up visits were not evaluated for efficacy. Results: By the final visit, the ACI had resolved in 64% (70/109) of patients in the Loteprednol etabonate group and 29% (33/113) of those in the placebo group ( P P Conclusion: Loteprednol etabonate 0.5% led to a clinically meaningful reduction in the signs and symptoms of postoperative ACI and had an acceptable safety profile when compared with a placebo.
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a randomized double masked placebo controlled parallel study of 0 2 Loteprednol etabonate in patients with seasonal allergic conjunctivitis
The Journal of Allergy and Clinical Immunology, 1998Co-Authors: Steven J Dell, George M Lowry, James A Northcutt, John Howes, Gary D Novack, Kathryn HartAbstract:Abstract Background: Loteprednol etabonate is a site-active corticosteroid with efficacy and safety in treating ocular inflammation at the 0.5% concentration. Evidence from dose-response studies suggested that the 0.2% concentration might be effective in treating ocular allergy. Objectives: The objective of this study was to evaluate the effects of 0.2% Loteprednol etabonate in reducing the signs and symptoms of seasonal allergic conjunctivitis. Methods: This was a randomized, double-masked, placebo-controlled, parallel-group multicenter study. Patients with signs and symptoms of environmental seasonal allergic conjunctivitis received either Loteprednol etabonate or placebo bilaterally four times daily for 42 days. Results: Enrolled were 133 patients (66 receiving Loteprednol etabonate; 67 receiving placebo). A reduction in severity was seen in both Loteprednol etabonate and placebo groups for bulbar conjunctival injection (1.3 vs 0.9 units on a 0 to 3 scale) and itching (3.5 vs 3.1 units on a 0 to 4 scale) over the first 2 weeks. The treatment effect was –0.5 and –0.6 units in favor of Loteprednol etabonate ( P Conclusions: Loteprenol etabonate (0.2%) was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate (0.2%) had a safety profile comparable to placebo during this 6-week trial. (J Allergy Clin Immunol 1998;102:251-5.)
Timothy L Comstock - One of the best experts on this subject based on the ideXlab platform.
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impact of the topical ophthalmic corticosteroid Loteprednol etabonate on intraocular pressure
Advances in Therapy, 2016Co-Authors: John D Sheppard, Timothy L Comstock, Megan E CavetAbstract:Corticosteroids are a mainstay therapeutic option for the treatment of ocular inflammation. However, safety remains a concern for clinicians, particularly with long-term use. Though highly effective at suppressing inflammatory and allergic responses, topical ophthalmic corticosteroids carry an inherent risk of side effects, including elevated intraocular pressure (IOP), a risk factor for the development of glaucoma. The corticosteroid Loteprednol etabonate (LE) contains an ester rather than a ketone at the C-20 position, minimizing the potential for side effects, including IOP elevation. In early pivotal clinical trials of LE ophthalmic suspension for conjunctivitis (allergic, giant papillary), anterior uveitis, and post-operative inflammation, LE had minimal impact on IOP over short-term (<28 days) and long-term (≥28 days) use. Since then, new LE formulations—including a gel, an ointment, and a suspension of LE in combination with tobramycin—have become commercially available. Multiple studies evaluating the safety and efficacy of LE for inflammatory conditions have been reported, including those requiring longer-term treatment such as photorefractive keratectomy, corneal transplantation, and dry eye disease. We review the available published data on the effect of LE on IOP and report on the cumulative incidence of clinically significant IOP elevations (≥10 mm Hg from baseline) with short-term and long-term LE use. In all studies, LE consistently demonstrated a low propensity to elevate IOP, regardless of formulation, dosage regimen, or treatment duration, including in known steroid responders. The cumulative proportion of patients exhibiting clinically significant IOP increases was 0.8% (14/1725 subjects) in studies evaluating short-term LE treatment and 1.5% (21/1386 subjects) in long-term studies. Furthermore, use of LE was associated with significantly lower rates of IOP elevation ≥10 mm Hg as compared to prednisolone acetate or dexamethasone (when used in combination with tobramycin). The cumulative data to date substantiates a favorable IOP-safety profile for LE with both short-term and long-term use.
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an update on the surgical management of pterygium and the role of Loteprednol etabonate ointment
Clinical Ophthalmology, 2014Co-Authors: John D Sheppard, Timothy L Comstock, Arnulfo Mansur, John A HovanesianAbstract:Pterygium, a sun-related eye disease, presents as wing-shaped ocular surface lesions that extend from the bulbar conjunctiva onto the cornea, most commonly on the nasal side. Pterygia show characteristic histological features that suggest that inflammation plays a prominent role in their initial pathogenesis and recurrence. Appropriate surgery is the key to successful treatment of pterygia, but there is also a rationale for the use of anti-inflammatory agents to reduce the rate of recurrence following surgery. Multiple surgical techniques have been developed over the last two millennia, but these initially had little success, due to high rates of recurrence. Current management strategies, associated with lower recurrence rates, include bare sclera excision and various types of grafts using tissue glues. Adjunctive therapies include mitomycin C and 5-fluorouracil, as well as the topical ocular steroid Loteprednol e tabon- ate, which has been shown to have a lower risk of elevated intraocular pressure than have the other topical ocular steroids. Here, the surgical management of pterygium is presented from a historical perspective, and current management techniques, including the appropriate use of various adjunctive therapies, are reviewed, along with an illustrative case presentation and a discussion of the conjunctival forceps designed to facilitate surgical management. Despite thousands of years of experience with this condition, there remains a need for a more thorough understanding of pterygium and interventions to reduce both its incidence and postsurgical recurrence. Until that time, the immediate goal is to optimize surgical practices to ensure the best possible outcomes. Loteprednol etabonate, especially the ointment formulation, appears to be a safe and effective component of the perioperative regimen for this complex ocular condi- tion, although confirmatory prospective studies are needed.
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Loteprednol etabonate ophthalmic gel 0 5 following cataract surgery integrated analysis of two clinical studies
Advances in Therapy, 2013Co-Authors: Rajesh K Rajpal, Raymond Fong, Timothy L ComstockAbstract:Introduction We aimed to evaluate the safety and efficacy of Loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.
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advances in corticosteroid therapy for ocular inflammation Loteprednol etabonate
International Journal of Inflammation, 2012Co-Authors: Timothy L Comstock, Heleen H DecoryAbstract:Topical corticosteroids are effective in reducing anterior segment inflammation but are associated with adverse drug reactions (ADRs) including elevation of intraocular pressure (IOP) and cataract formation. Retrometabolic drug design has advanced the development of new corticosteroids with improved therapeutic indices. Engineered from prednisolone, Loteprednol etabonate (LE) has a 17α-chloromethyl ester, in lieu of a ketone group, and a 17β-etabonate group. LE is highly lipophilic and binds with high affinity to the glucocorticoid receptor; any unbound LE is metabolized to inactive metabolites. LE has been studied in several anterior segment inflammatory conditions (giant papillary conjunctivitis, allergic conjunctivitis, anterior uveitis, and keratoconjunctivitis sicca), and in postoperative ocular inflammation and pain. Combined with tobramycin, it is effective in blepharokeratoconjunctivitis. Elevations in IOP are infrequent with LE, and the absence of a C-20 ketone precludes formation of Schiff base intermediates with lens proteins, a common first step implicated in cataract formation with ketone steroids.
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Safety and efficacy of Loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
Dove Medical Press, 2011Co-Authors: Timothy L Comstock, Michael R Paterno, Angele SinghAbstract:Timothy L Comstock1 Michael R Paterno1 Angele Singh1 Tara Erb1 Elizabeth Davis21Bausch and Lomb Inc., Rochester, NY, USA; 2Minnesota Eye Consultants, Bloomington, MN, USABackground: To compare the safety and efficacy of Loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery.Methods: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged ≥18 years with a combined postoperative anterior chamber cells and flare (ACI) ≥ Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings.Results: Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P < 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P < 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure ≥10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment.Conclusion: LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.Keywords: Loteprednol etabonate, ophthalmic ointment, postoperative inflammation, postoperative pain, cataract surgery, intraocular pressur
Edward J Holland - One of the best experts on this subject based on the ideXlab platform.
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effect of Loteprednol etabonate 0 5 on initiation of dry eye treatment with topical cyclosporine 0 05
Eye & Contact Lens-science and Clinical Practice, 2014Co-Authors: John D Sheppard, Charles B Slonim, Stephen S Lane, Edward J Holland, Eric D Donnenfeld, Renee Solomon, Kerry D Solomon, Marguerite B Mcdonald, Henry D Perry, Stephen C PflugfelderAbstract:Objective: The purpose of this work was to evaluate the effect of Loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043). Methods: Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients selfadministered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity. Results: Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P,0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. Conclusions: Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.
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Loteprednol etabonate 0 5 versus prednisolone acetate 1 0 for the treatment of inflammation after cataract surgery
Journal of Cataract and Refractive Surgery, 2013Co-Authors: Stephen S Lane, Edward J HollandAbstract:Purpose To evaluate the efficacy of Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the control of postoperative inflammation in patients having routine cataract surgery. Setting Private practice, Stillwater, Minnesota, and Cincinnati Eye Institute, Cincinnati, Ohio, USA. Design Comparative case series. Methods Patients were at least 18 years of age and scheduled for routine cataract surgery. Patients were excluded from the study if they had preexisting medical conditions (ie, elevated intraocular pressure [IOP], retinopathy, maculopathy, uveitis) or required medications the investigator believed would put the patient at risk or confound the study. Patients were randomized to receive Loteprednol etabonate or prednisolone acetate 4 times daily in addition to bromfenac 0.09% and besifloxacin 0.6% after surgery. Visual acuity, IOP, and anterior chamber cell and flare intensity were assessed over 3 weeks after cataract surgery. The primary endpoint was the level of anterior chamber cell and flare intensity in patients treated with Loteprednol etabonate or prednisolone acetate. Results The study enrolled 88 patients (46 Loteprednol etabonate, 42 prednisolone acetate). Equivalency was achieved between the 2 treatment groups with no significant differences throughout the 3-week follow-up. There was less fluctuation in IOP assessments in patients treated with Loteprednol etabonate than in patients treated with prednisolone acetate, in particular 1 day and 3 days postoperatively. Conclusions The results indicate that equivalent control of inflammation can be obtained through treatment with Loteprednol etabonate or prednisolone acetate after cataract surgery. In addition, treatment with Loteprednol etabonate may result in less IOP fluctuation. Financial Disclosure Dr. Lane is a consultant to Bausch & Lomb, Rochester, New York, Alcon Laboratories, Inc., Fort Worth, Texas, and ISTA Pharmaceuticals, Irvine, California, USA. Dr. Holland is a consultant to Bausch & Lomb, Rochester, New York, and Alcon Laboratories, Inc., Fort Worth, Texas, USA. Neither author has a financial or proprietary interest in any material or method mentioned.
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attenuation of ocular hypertension with the use of topical Loteprednol etabonate 0 5 in steroid responders after corneal transplantation
Cornea, 2009Co-Authors: Edward J Holland, Ali R Djalilian, Jeffrey P SandersonAbstract:Purpose To describe a clinically observed reduction in intraocular pressure (IOP) without increased allograft rejection in known "steroid responders" using Loteprednol etabonate 0.5% ophthalmic suspension as second-line rescue therapy after corneal transplantation. Methods Medical records from a prespecified 15-month period were retrospectively reviewed for all post-corneal transplant patients in whom Loteprednol etabonate was initiated and prednisolone acetate 1.0% ophthalmic suspension withdrawn because of a secondary increase in IOP. Elevated postoperative IOP was defined as IOP that increased > or =21 mm Hg. Baseline IOP values were compared with IOP readings at follow-up examinations, with data points set retrospectively at 0-4, 4-8, 8-16, 16-32, and >32 weeks. Patient records were evaluated for any signs of allograft rejection during Loteprednol etabonate therapy. Results Thirty patients were found to have switched to Loteprednol etabonate after an increase in IOP during postoperative prednisolone acetate treatment. The mean reduction in IOP observed when comparing initial and final values in all 30 patients was 12.9 mm Hg during a mean follow-up of 21.6 weeks. The mean percent reduction in IOP during Loteprednol etabonate treatment was 32.6% at 3 weeks and 44.9% at 39 weeks. No clinically observed signs of allograft rejection were documented. Conclusions Switching to Loteprednol etabonate from prednisolone acetate in known steroid responders was successful in reducing IOP and did not increase the risk of allograft rejection. Because of its lower potential for causing elevated IOP, Loteprednol etabonate should be considered in the prophylaxis of allograft rejection in steroid responders.
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effects of Loteprednol tobramycin versus dexamethasone tobramycin on intraocular pressure in healthy volunteers
Cornea, 2008Co-Authors: Edward J Holland, Michael R Paterno, Jimmy D Bartlett, Dale W Usner, Timothy L ComstockAbstract:Purpose To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension. Methods Three hundred six healthy volunteers received either Loteprednol etabonate/tobramycin (n = 156) or dexamethasone/tobramycin (n = 150) at 4-hour intervals 4 times a day in both eyes for 28 days in this randomized, double-masked, multicenter, parallel-group trial. IOP, visual acuity (VA), and ocular health were assessed at all study visits (days 1, 3, 8, 15, 22, and 29), whereas undilated direct ophthalmoscopy was completed at the baseline and final visits. Adverse events (AEs) were assessed at all follow-up visits. Results The number of subjects experiencing IOP increases of >or=10 mm Hg from baseline at any study visit for the Loteprednol etabonate/tobramycin group (3 subjects, 1.95%) was significantly lower than that for the dexamethasone/tobramycin group (11 subjects, 7.48%; P = 0.0280), as were mean changes from baseline IOP (P or=2 lines at any visit were observed in 14 (4.55%) eyes for Loteprednol etabonate/tobramycin and in 23 (7.82%) eyes for dexamethasone/tobramycin (P = 0.1257). Both treatments were well tolerated. Conclusions Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both Loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.
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a randomized double masked placebo controlled multicenter comparison of Loteprednol etabonate ophthalmic suspension 0 5 and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance
American Journal of Ophthalmology, 2004Co-Authors: Stephen C Pflugfelder, Edward J Holland, Steven L Maskin, Bruce Anderson, James Chodosh, Cintia S De Paiva, Stephen P Bartels, Teresa Micuda, Howard M Proskin, Roger VogelAbstract:Purpose To evaluate Loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance. Design Randomized, double-masked, placebo-controlled clinical trial. Methods Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either Loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms. Results In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the Loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the Loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported. Conclusion The use of topical Loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.
Raymond Fong - One of the best experts on this subject based on the ideXlab platform.
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submicron Loteprednol etabonate ophthalmic gel 0 38 for the treatment of inflammation and pain after cataract surgery
Journal of Cataract and Refractive Surgery, 2018Co-Authors: Raymond Fong, Bruce E Silverstein, James H Peace, Jon I Williams, Jason L VittitowAbstract:Purpose To assess the safety and efficacy of a 0.38% submicron formulation of Loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. Setting Forty-five United States ophthalmology practices. Design Double-masked vehicle-controlled randomized parallel group study. Methods Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). Results The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P Conclusion In this study, submicron Loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.
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Loteprednol etabonate ophthalmic gel 0 5 following cataract surgery integrated analysis of two clinical studies
Advances in Therapy, 2013Co-Authors: Rajesh K Rajpal, Raymond Fong, Timothy L ComstockAbstract:Introduction We aimed to evaluate the safety and efficacy of Loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.
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Loteprednol etabonate gel 0 5 for postoperative pain and inflammation after cataract surgery results of a multicenter trial
Clinical Ophthalmology, 2012Co-Authors: Raymond Fong, Raphaele Sioumermet, Martin Alexander Leitritz, Tara ErbAbstract:Purpose Loteprednol etabonate (LE) is approved by the US FDA in a suspension and ointment form (0.5%) for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH.
