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

Phase 3

Completed

• Conditions: Acute Bacterial Conjunctivitis
• Interventions: Drug: Vehicle; Drug: ISV-403

• Registration Number: NCT00347932
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2009-06-29
• Results First Submitted QC: 2009-08-12
• Results First Posted: 2009-08-13
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 957

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle of ISV-403 ophthalmic suspension
ISV-403	ISV-403	0.6% ISV-403 ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Clinical Resolution of Baseline Bacterial Conjunctivitis	Day 5 +/- 1 day	The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection	Day 5 +/- 1 day	Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

Secondary Outcome Measures

Name	Time	Method
Clinical Resolution of Baseline Bacterial Conjunctivitis	Day 8 or 9	The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Microbial Eradication of Baseline Bacterial Infection	Day 8 or 9	Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.