Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Phase 3CompletedNCT00586625

Bausch & Lomb Incorporated861 enrolled

Overview

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

861

Conditions

Allergic Conjunctivitis

Interventions

BepreveDRUG

One drop, both eyes, twice a day

PlaceboDRUG

One drop, both eyes, twice a day

Eligibility

Sex: ALLMin age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must be at least 3 years of age, and have ocular health within normal limits Exclusion Criteria: * No active ocular disease

Outcomes

Primary Outcomes

Ocular Comfort

A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable

Time frame: Day 8 & Day 22

Data from ClinicalTrials.gov

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