Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

Alcon Research

Overview

To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Bacterial Conjunctivitis

Interventions

AL-15469A 0.5% and AL-6515 0.3% Ophthalmic SuspensionDRUG

Topical ocular dosed 3 times per day for 3 days

AL-15469A 0.5%DRUG

Topical ocular dosed 3 times per day for 3 days

AL-6515 0.3%DRUG

Topical ocular dosed 3 times per day for 3 days

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients of any race * 5 years of age and older at the time of the Day 1 visit * with a primary clinical diagnosis of bacterial conjunctivitis. Exclusion Criteria: * Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days * Presence of punctal plug or punctal occlusion * Visual Acuity worse than 20/80 * Upper respiratory infection

Outcomes

Primary Outcomes

Sustained Clinical Cure rate

Time frame: Day 3

End of therapy Clinical Cure rate

Time frame: Day 4

Secondary Outcomes

Sustained bulbar conjunctival injection

Time frame: Day 3

Microbiological Success

Time frame: Day 4

Data from ClinicalTrials.gov

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