Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Phase 2

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: Vehicle (Placebo); Drug: Besifloxacin

• Registration Number: NCT00972777
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Start: 2009-10
• Primary Completion: 2010-10
• Study Completion: 2011-02
• Results First Submitted: 2012-01-12
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-14
• Last Update Submitted: 2012-02-14
• Results First Posted: 2012-03-29
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

• Subjects who are at least one year of age.
• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
• Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria

• Subjects who have any uncontrolled systemic disease or debilitating disease.
• Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
• Subjects who are expected to require treatment with any disallowed medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle (Placebo)	-
Besifloxacin	Besifloxacin	0.6% ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Clinical Resolution	Visit 2	The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication	Visit 2	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Secondary Outcome Measures

Name	Time	Method
Clinical Resolution	Visit 3	The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication	Visit 3	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States