MedTrace Logo

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

NCT01443442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-08-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Allergic Conjunctivitis

Interventions

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

Sponsors & Collaborators

  • Southern California College of Optometry at Marshall B. Ketchum University

    lead OTHER

Principal Investigators

  • Judy Tong, OD · Southern California College of Optometry at Marshall B. Ketchum University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443442 on ClinicalTrials.gov