Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis - Full Text View

Sponsor:	Bausch & Lomb, Inc.
Information provided by (Responsible Party):	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00972777

Purpose

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.

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: Besifloxacin Drug: Vehicle (Placebo)	Phase 2 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Besifloxacin

U.S. FDA Resources

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Clinical Resolution [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Secondary Outcome Measures:

Clinical Resolution [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
The absence of both conjunctival discharge and bulbar conjunctival injection.
Microbial Eradication [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

Enrollment:	474
Study Start Date:	October 2009
Study Completion Date:	February 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Besifloxacin 0.6% ophthalmic suspension	Drug: Besifloxacin Besifloxacin 0.6% administered into the study eye two times a day for three days. Other Name: Besivance
Placebo Comparator: Vehicle	Drug: Vehicle (Placebo) Vehicle administered to the study eye two times a day for three days.

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972777

Locations

United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Michael R Paterno, OD

Bausch & Lomb, Inc.

More Information

No publications provided by Bausch & Lomb, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26.

Responsible Party:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00972777 History of Changes
Other Study ID Numbers:	603
Study First Received:	September 4, 2009
Results First Received:	January 12, 2012
Last Updated:	February 14, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection

Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012