A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

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

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Besifloxacin

Criteria

Inclusion Criteria:

• Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.

• Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

• Pregnant or nursing females.

• Known hypersensitivity to fluoroquinolones or to any of the study ingredients.

• Use of any antibiotic within 72 hours of treatment.

• Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.

• Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.