Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in

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 Summary:
Sponsor: Alcon Research

Current Primary Outcome:

• Clinical Cure Rate [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome:

• Clinical Cure Rate [ Time Frame: Day 9 ]
  The investigator will rate the ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) in each eye of the patient. Bulbar conjunctival injection and conjunctival discharge/exudates will be rated on a 4-point scale ranging from 0 to 3, with 0 = normal/absent; 1 = mild; 2 = moderate, and 3 = severe. Clinical cure will be considered attained if the sum of the ocular signs of bacterial conjunctivitis is 0.
• Microbiological Success Rate [ Time Frame: Day 9 ]
  Microbiological specimen(s) from the patient's affected eye(s) will be collected according to a protocol-defined process. Microbiological success will be considered attained if the pre-therapy pathogens are eradicated.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alcon Research

Dates:
Date Received: April 6, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 27, 2015
Last Verified: April 2015