NEWS HIGHLIGHTS
Published Studies Related to Alrex (Loteprednol Ophthalmic)
Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. [2008.01]
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... 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.
Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. [2008.01]
CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP. Limitation: Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.
Comparison of tobramycin 0.3%/dexamethasone 0.1% and tobramycin 0.3%/loteprednol 0.5% in the management of blepharo-keratoconjunctivitis. [2007.01]
In this clinical trial, investigators compared the effectiveness of 2 commercially formulated antibiotic/steroid combinations - tobramycin 0.3%/dexamethasone 0.1% (Tobradex; Alcon, Fort Worth, Tex) and tobramycin 0.3%/loteprednol 0.5% (Zylet; Bausch & Lomb Inc., Rochester, NY) - for rapidly controlling inflammation in patients with blepharo-keratoconjunctivitis...
Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit. [2005.03]
BACKGROUND: Loteprednol etabonate (LE) is a novel soft steroid that was designed to improve the benefit/risk ratio of topical corticosteroid therapy. This study assesses the clinical efficacy and safety of three different doses of LE nasal spray in seasonal allergic rhinitis (SAR)... CONCLUSIONS: Loteprednol 400 microg once daily is superior to placebo and the only effective dose tested in improving nasal symptoms and objective parameters in patients with SAR.
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. [2004.09]
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... 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.
Clinical Trials Related to Alrex (Loteprednol Ophthalmic)
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye [Completed]
This was a single-center, randomized, double-masked, placebo-controlled, parallel-group,
4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects
were randomized to receive loteprednol etabonate ophthalmic suspension, 0. 5% or placebo
(vehicle of loteprednol etabonate ophthalmic suspension, 0. 5%) and instructed to dose
bilaterally either TID or QID according to randomization.
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis [Recruiting]
The objective of this study is to evaluate the safety and effectiveness of Zylet in
comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of
blepharoconjunctivitis in pediatric subjects.
Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery [Recruiting]
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic
base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation [Completed]
The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the
prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan,
Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and
Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch &
Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
Safety and Efficacy of Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle for the Treatment of Inflammation Following Cataract Surgery [Recruiting]
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment,
0. 5% vs. vehicle for the treatment of inflammation following cataract surgery
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