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

Phase 2

Withdrawn

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: AL-6515 0.3%; Drug: Vehicle; Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension; Drug: AL-15469A 0.5%

• Registration Number: NCT01238783
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Study Start: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-29
• Primary Completion: 2011-12
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AL-6515 0.3%	AL-6515 0.3%	-
Vehicle	Vehicle	-
AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension	AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension	-
AL-15469A 0.5%	AL-15469A 0.5%	-

Primary Outcome Measures

Name	Time	Method
End of therapy Clinical Cure rate	Day 4
Sustained Clinical Cure rate	Day 3

Secondary Outcome Measures

Name	Time	Method
Sustained bulbar conjunctival injection	Day 3
Microbiological Success	Day 4