Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

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.

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: Besifloxacin; Drug: Vehicle (Placebo)

• Study Type: Interventional
• Enrollment (Actual): 474
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle (Placebo); Vehicle administered to the study eye two times a day for three days.
Experimental: Besifloxacin; 0.6% ophthalmic suspension	Drug: Besifloxacin; Besifloxacin 0.6% administered into the study eye two times a day for three days.; Other Names: Besivance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Michael R Paterno, OD, Bausch & Lomb Incorporated

Publications and helpful links

General Publications

• Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25.
• DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000.
• 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. doi: 10.1016/j.clinthera.2010.12.004.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: September 4, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): March 29, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Besifloxacin
• Other Study ID Numbers: 603