Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

Phase 3

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Other: Moxifloxacin AF Vehicle; Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%

• Registration Number: NCT00759148
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-02-23
• Results First Submitted QC: 2011-02-23
• Results First Posted: 2011-03-22
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1179

Inclusion Criteria

• Diagnosed with bacterial conjunctivitis in 1 or both eyes;
• Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
• Agrees to comply with the visit schedule and other requirements of the study;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
• Presence of concomitant viral infection;
• Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
• Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
• Infants undergoing treatment for retinopathy of prematurity;
• Contact lens wear during the course of the study;
• Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
• Use of medications, as specified in the protocol;
• Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
• Known or suspected allergy or hypersensitivity to fluoroquinolones;
• Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Moxifloxacin AF Vehicle	Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Moxifloxacin AF	Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%	Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days

Primary Outcome Measures

Name	Time	Method
Clinical Cure at the Day 4 (EOT)/Exit Visit	Day 4	Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.

Secondary Outcome Measures

Name	Time	Method
Microbiological Success at the Day 4 (EOT)/Exit Visit	Day 4	Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.