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 Chinese Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 985
- Locations
- 1
- Primary Endpoint
- Clinical Cure Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
Moxifloxacin
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
Intervention: Moxifloxacin ophthalmic solution, 0.5% (Drug)
Ofloxacin
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
Intervention: Ofloxacin ophthalmic solution, 0.3% (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported