Allergic Conjunctivitis Clinical Trial
Official 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
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.
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
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