NCT01443442

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigator and Study Center: Judy Tong, OD Eye Care Center Southern California College of Optometry Test Product, Dose and Mode of Administration: Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol etabonate ophthalmic suspension) 0.2% qid ou Study Title: 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 Primary Objective(s): The primary objective of this study is to compare 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 patients over the age of 18 years of age Study Design: Interventional, Randomized, Parallel Arm, Investigator Masked Study Population: Subjects over the age of 18 years of age with moderate to severe allergic conjunctivitis. Duration of Treatment: 14 days Efficacy Assessments: Itching, Bulbar conjunctival injection, Bulbar conjunctival chemosis Safety Assessments: N/A

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	bepotastine besilate, 1.5%	Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
DRUG	Loteprednol etabonate	Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-09-29
• Last updated: 2019-08-06
• Results posted: 2019-08-06

Locations

2 sites across 1 country: United States