CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
bepotastine besilate, 1.5% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01443442
NCT01443442Phase 4Completed

A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis

Southern California College of Optometry at Marshall B. Ketchum University·interventional·Posted Sep 29, 2011·Updated Aug 6, 2019

In Brief

A Phase 4 clinical trial evaluating bepotastine besilate, 1.5% and Loteprednol etabonate for Allergic Conjunctivitis. Completed, enrolled 23 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.8 years ago

Interventions

bepotastine besilate, 1.5%drug

Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days

Loteprednol etabonatedrug

Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days