Phase 3
N=982
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
Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01573910 ↗Enrolled (actual)
982
Serious AEs
0.1%
Results posted
May 2015
Primary outcome: Primary: Clinical Cure Rate — 85.4; 81.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxifloxacin ophthalmic solution, 0.5% (Drug); Ofloxacin ophthalmic solution, 0.3% (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure Rate |
85.4; 81.4 | — |
| PRIMARY Microbiological Success Rate |
95.3; 94.8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01573910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.