Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Bacterial Conjunctivitis Clinical Trial

Official title:

A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972777
• Other study ID #: 603
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 4, 2009
• Last updated: February 14, 2012
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Besifloxacin
Besifloxacin 0.6% administered into the study eye two times a day for three days.
• Vehicle (Placebo)
Vehicle administered to the study eye two times a day for three days.

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Resolution	The absence of both conjunctival discharge and bulbar conjunctival injection.	Visit 2	No
Primary	Microbial Eradication	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.	Visit 2	No
Secondary	Clinical Resolution	The absence of both conjunctival discharge and bulbar conjunctival injection.	Visit 3	No
Secondary	Microbial Eradication	The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.	Visit 3	No