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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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


Sponsor: Southern California College of Optometry

Current Primary Outcome:

  • Change from Baseline in Ocular Itching [ Time Frame: Change from Baseline in Ocular Itching at 14 Days ]
    Ocular itching on a 0 - 4 scale in 0,5 scale unit increments
  • Change from Baseline in Bulbar Redness [ Time Frame: Change from Baseline in Bulbar Redness at 14 Days ]
    Bulbar Redness, measured on a 0 - 4 scale using 0.5 unit increments


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Southern California College of Optometry

Dates:
Date Received: September 27, 2011
Date Started: October 2011
Date Completion:
Last Updated: January 18, 2013
Last Verified: January 2013