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Alrex (Loteprednol Etabonate Ophthalmic) - Summary



ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.

ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

See all Alrex indications & dosage >>


Published Studies Related to Alrex (Loteprednol Ophthalmic)

Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. [2014]
randomized double-masked parallel group clinical study (NCT00407043)... CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the

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.

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Clinical Trials Related to Alrex (Loteprednol Ophthalmic)

Alrex� Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC) [Completed]

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis [Completed]
Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and burning. This is a randomized clinical study to evaluate the efficacy of Bepreve (bepotastine besilate 1. 5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0. 2%) in the treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years. The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms (itching) will be monitored as outcome variables.

Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis [Active, not recruiting]
This is a Phase IV, single site, randomized, double masked, parallel control clinical trial of 60 subjects to investigate the variance of efficacy between Lotemax and Zylet for treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of meibomian gland dysfunction and validated ocular symptom assessment questionnaire.

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5% [Active, not recruiting]
The purpose of this research is to: 1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness. 2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant. 3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis [Completed]
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.

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Reports of Suspected Alrex (Loteprednol Ophthalmic) Side Effects

Eye Irritation (2)Drug Hypersensitivity (2)Condition Aggravated (2)Lacrimation Increased (2)Drug Ineffective (1)Drug Ineffective FOR Unapproved Indication (1)Vitreous Floaters (1)Eye Pruritus (1)Swelling Face (1)Rash Generalised (1)more >>

Page last updated: 2015-08-10

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