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Timothy L Comstock - One of the best experts on this subject based on the ideXlab platform.
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Loteprednol Etabonate 0 5 tobramycin 0 3 compared with dexamethasone 0 1 tobramycin 0 3 for the treatment of blepharitis
Ocular Immunology and Inflammation, 2017Co-Authors: Timothy L Comstock, Heleen H DecoryAbstract:ABSTRACTPurpose: To compare the efficacy of Loteprednol Etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in reducing select signs of blepharitis.Methods: Data were pooled from two studies (one from the USA; one from China) of adults (n = 627) with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks (safety population). Efficacy analyses included 495 eyes (247 LE/T, 248 DM/T) with any baseline sign of blepharitis.Results: At Day 15, the least squares mean change from baseline in composite blepharitis severity was similar between LE/T (–2.86) and DM/T (–2.99) (90% CI for mean treatment difference: –0.35, 0.11). Intraocular pressure (IOP) increases ≥10 mmHg over baseline were reported for 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).Conclusions: LE/T was similarly effective in reducing the signs of blepharitis compared with DM/T, but demonstrated a better safety profile with respect to changes in IOP.
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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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safety and tolerability of Loteprednol Etabonate 0 5 and tobramycin 0 3 ophthalmic suspension in pediatric subjects
Pediatric Drugs, 2012Co-Authors: Timothy L Comstock, Heleen H Decory, Michael R Paterno, Kirk Bateman, Matthew GearingerAbstract:Loteprednol Etabonate 0.5% and tobramycin 0.3% ophthalmic suspension (LE/T) is indicated for steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. LE/T was shown to be safe in healthy volunteers and patients aged 18 years and older with minimal effect on intraocular pressure (IOP). The aim of the study was to evaluate the safety of LE/T in pediatric subjects by examining data from two clinical studies. Two randomized, multicenter, double-masked, parallel-group (one two-arm, the other four-arm) studies were conducted in subjects aged 0–6 years (N = 245). One study assessed LE/T compared with vehicle in the management of lid inflammation (n = 108) and the other compared LE/T with Loteprednol Etabonate ophthalmic suspension 0.5% (LE), tobramycin ophthalmic solution 0.3% (tobramycin), and vehicle in the treatment of blepharoconjunctivitis (n = 137). In the first study, subjects were randomized to LE/T or vehicle administered four times daily (qid) for the first 7 days followed by twice daily (bid) for 7 days along with warm compresses bid for the entire 2 weeks. In the second study, subjects were randomized to LE/T, LE, tobramycin, or vehicle administered qid for 14 days. Treatment-emergent ocular and non-ocular adverse events (AEs) and bilateral vision were assessed at all study visits in both studies. In addition, in the lid inflammation study, IOP was assessed at all visits. The primary safety endpoint in both studies was the incidence of treatment-emergent AEs. The incidence of LE/T treatment-emergent AEs was low. A total of four ocular AEs were reported for three LE/T-treated subjects in the first study (conjunctivitis [two events], meibomian gland dysfunction, and corneal staining), and one ocular AE was reported for an LE/T-treated subject in the second study (eye pain). A total of 13 non-ocular AEs were reported for eight LE/T-treated subjects in the two trials. The most prevalent non-ocular AEs were pyrexia (three events) and rash (two events). There were no differences in the incidence of specific ocular and non-ocular AEs between the LE/T group and the comparator treatment group. In both studies, there were no clinically meaningful reductions in vision at follow-up visits. Mean IOP and IOP changes from baseline, assessed in the lid inflammation study, were not different between LE/T and vehicle treatment groups at any study visits. The results of these two clinical trials demonstrate the short-term safety of treatment with topical LE/T in pediatric subjects (0–6 years of age) with lid inflammation or blepharoconjunctivitis.
Heleen H Decory - One of the best experts on this subject based on the ideXlab platform.
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Loteprednol Etabonate submicron ophthalmic gel 0 38 dosed three times daily following cataract surgery integrated analysis of two phase iii clinical studies
Clinical Ophthalmology, 2019Co-Authors: Raymond Fong, Megan E Cavet, Heleen H Decory, Jason L VittitowAbstract:Purpose To evaluate the efficacy and safety of a submicron formulation of Loteprednol Etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies. Patients and methods Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6-15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms). Results The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P 75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel. Conclusion The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.
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Loteprednol Etabonate 0 5 tobramycin 0 3 compared with dexamethasone 0 1 tobramycin 0 3 for the treatment of blepharitis
Ocular Immunology and Inflammation, 2017Co-Authors: Timothy L Comstock, Heleen H DecoryAbstract:ABSTRACTPurpose: To compare the efficacy of Loteprednol Etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in reducing select signs of blepharitis.Methods: Data were pooled from two studies (one from the USA; one from China) of adults (n = 627) with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks (safety population). Efficacy analyses included 495 eyes (247 LE/T, 248 DM/T) with any baseline sign of blepharitis.Results: At Day 15, the least squares mean change from baseline in composite blepharitis severity was similar between LE/T (–2.86) and DM/T (–2.99) (90% CI for mean treatment difference: –0.35, 0.11). Intraocular pressure (IOP) increases ≥10 mmHg over baseline were reported for 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).Conclusions: LE/T was similarly effective in reducing the signs of blepharitis compared with DM/T, but demonstrated a better safety profile with respect to changes in IOP.
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development of a non settling gel formulation of 0 5 Loteprednol Etabonate for anti inflammatory use as an ophthalmic drop
Clinical Ophthalmology, 2013Co-Authors: Martin J Coffey, Heleen H Decory, Stephen S LaneAbstract:The eye has protective barriers (ie, the conjunctival and corneal membranes) and defense mechanisms (ie, reflex tearing, blinking, lacrimal drainage) which present challenges to topical drug delivery. Topical ocular corticosteroids are commonly used in the treatment of anterior segment diseases and inflammation associated with ocular surgery, and manufacturers continually strive to improve their characteristics. We describe the development of a novel ophthalmic gel formulation of Loteprednol Etabonate (LE), a C-20 ester-based corticosteroid with an established safety profile, in the treatment of ocular inflammatory conditions. The new LE gel formulation is non-settling, eliminating the need to shake the product to resuspend the drug, has a pH close to that of tears, and a low preservative concentration. The rheological characteristics of LE gel are such that the formulation is instilled as a drop and transitions to a fluid upon instillation in the eye, yet retains sufficient viscosity to prolong ocular surface retention. The new formulation provides consistent, uniform dosing as evidenced by dose extrusion studies, while pharmacokinetic studies in rabbits demonstrated rapid and sustained exposure to LE in ocular tissues following instillation of LE gel. Finally, results from two clinical studies of LE gel in the treatment of postoperative inflammation and pain following cataract surgery indicate that it was safe and effective. Most patients reported no unpleasant drop sensation upon instillation, and reports of blurred vision were rare.
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safety and tolerability of Loteprednol Etabonate 0 5 and tobramycin 0 3 ophthalmic suspension in pediatric subjects
Pediatric Drugs, 2012Co-Authors: Timothy L Comstock, Heleen H Decory, Michael R Paterno, Kirk Bateman, Matthew GearingerAbstract:Loteprednol Etabonate 0.5% and tobramycin 0.3% ophthalmic suspension (LE/T) is indicated for steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. LE/T was shown to be safe in healthy volunteers and patients aged 18 years and older with minimal effect on intraocular pressure (IOP). The aim of the study was to evaluate the safety of LE/T in pediatric subjects by examining data from two clinical studies. Two randomized, multicenter, double-masked, parallel-group (one two-arm, the other four-arm) studies were conducted in subjects aged 0–6 years (N = 245). One study assessed LE/T compared with vehicle in the management of lid inflammation (n = 108) and the other compared LE/T with Loteprednol Etabonate ophthalmic suspension 0.5% (LE), tobramycin ophthalmic solution 0.3% (tobramycin), and vehicle in the treatment of blepharoconjunctivitis (n = 137). In the first study, subjects were randomized to LE/T or vehicle administered four times daily (qid) for the first 7 days followed by twice daily (bid) for 7 days along with warm compresses bid for the entire 2 weeks. In the second study, subjects were randomized to LE/T, LE, tobramycin, or vehicle administered qid for 14 days. Treatment-emergent ocular and non-ocular adverse events (AEs) and bilateral vision were assessed at all study visits in both studies. In addition, in the lid inflammation study, IOP was assessed at all visits. The primary safety endpoint in both studies was the incidence of treatment-emergent AEs. The incidence of LE/T treatment-emergent AEs was low. A total of four ocular AEs were reported for three LE/T-treated subjects in the first study (conjunctivitis [two events], meibomian gland dysfunction, and corneal staining), and one ocular AE was reported for an LE/T-treated subject in the second study (eye pain). A total of 13 non-ocular AEs were reported for eight LE/T-treated subjects in the two trials. The most prevalent non-ocular AEs were pyrexia (three events) and rash (two events). There were no differences in the incidence of specific ocular and non-ocular AEs between the LE/T group and the comparator treatment group. In both studies, there were no clinically meaningful reductions in vision at follow-up visits. Mean IOP and IOP changes from baseline, assessed in the lid inflammation study, were not different between LE/T and vehicle treatment groups at any study visits. The results of these two clinical trials demonstrate the short-term safety of treatment with topical LE/T in pediatric subjects (0–6 years of age) with lid inflammation or blepharoconjunctivitis.
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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.
John Howes - One of the best experts on this subject based on the ideXlab platform.
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the effects of delta1 cortienic acid on skin blanching pharmacokinetics and stability of Loteprednol Etabonate
Die Pharmazie, 2012Co-Authors: Erik Bodor, John Howes, Nicholas BodorAbstract:The effect of delta1-cortienic acid (delta1-CA) on human skin blanching activity of the soft corticosteroid, Loteprednol Etabonate (LE), has been studied. Ten volunteers had applied to their forearms a dose of LE ranging from 0.1 to 1 mM, or LE from 0.1 to 1 mM in combination with 2-times the concentration of delta1-CA (0.2 - 2mM). The results indicate that delta1-CA increased LE's effect on human vasoconstriction/skin blanching activity, both in the intensity and duration. This enhancing effect of delta1-CA was also observed in other blanching studies with other corticosteroids, such as hydrocortisone. The enhancement may occur through the displacement of LE bound to transcortin (also known as corticosteroid-binding globulin, or CBG) by delta1-CA as delta1-CA has a higher affinity for CBG than that for glucocorticoid receptor (GR), resulting in more free-LE to act on GR, and increased skin blanching. In rat studies, intravenous injection of delta1-CA (5-50 mg/kg) did not affect the pharmacokinetics of LE (5 mg/kg), indicating that delta1-CA is safe for combined use with LE. In stability studies, the presence of delta1-CA at the same concentrations as LE in aqueous suspension (0.1 and 0.2%) significantly increased the stability of LE. Thus, the combination of delta1-CA with LE serves an enhancing and stabilizing role while not impacting the pharmacokinetic properties of LE.
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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.
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.)
Jason L Vittitow - One of the best experts on this subject based on the ideXlab platform.
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Loteprednol Etabonate gel 0 5 vs prednisolone acetate suspension 1 for the treatment of inflammation after cataract surgery in children
Journal of Cataract and Refractive Surgery, 2020Co-Authors: Jason L Vittitow, Jon I WilliamsAbstract:Purpose To compare Loteprednol Etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children. Setting Eleven sites in the United States. Design Randomized, double-masked, parallel-group, noninferiority study. Methods Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure. Results The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases. Conclusions LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.
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Loteprednol Etabonate submicron ophthalmic gel 0 38 dosed three times daily following cataract surgery integrated analysis of two phase iii clinical studies
Clinical Ophthalmology, 2019Co-Authors: Raymond Fong, Megan E Cavet, Heleen H Decory, Jason L VittitowAbstract:Purpose To evaluate the efficacy and safety of a submicron formulation of Loteprednol Etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies. Patients and methods Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6-15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms). Results The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P 75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel. Conclusion The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.
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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.
