drugset / Trial / NCT01443442

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

NCT01443442

RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2011-10
Primary completion
2012-09
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bepotastine Small molecule 1.5 % Topical
Comparator Loteprednol Etabonate Other / unclassified 0.2 % Topical

Indications