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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Fluoroquinolones; Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.

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.