An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

Phase 3

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Moxifloxacin ophthalmic solution, 0.5%; Drug: Ofloxacin ophthalmic solution, 0.3%

• Registration Number: NCT01573910
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Study Start: 2012-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-04
• Results First Submitted: 2015-04-27
• Results First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Results First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 985

Inclusion Criteria

• Chinese.
• Diagnosis of bacterial conjunctivitis based on clinical observation.
• Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
• Willing to complete all required study procedures and visits.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Women who are pregnant, lactating, or planning a pregnancy.
• Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
• Planned contact lens wear during the course of the study.
• Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
• Suspected fungal, viral, or Acanthamoeba infection.
• Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
• History of recent surgery.
• Presence of concomitant systemic viral infection.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin ophthalmic solution, 0.5%	Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9
Ofloxacin	Ofloxacin ophthalmic solution, 0.3%	Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate	Day 9	Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
Microbiological Success Rate	Day 9	Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.

Trial Locations

Locations (1)

Alcon (China) Ophthalmic Product Co., Ltd.; 🇨🇳 Beijing, China