Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days

The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: Besivance; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
• Subjects who are willing to discontinue contact lens wear for the duration of the study.
• Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

• Subjects who have any uncontrolled systemic disease or debilitating disease.
• Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
• Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
• Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
• Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
• Subjects with suspected iritis.
• Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
• Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
• Subjects who are immune compromised.

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
Experimental: Besivance; besifloxacin ophthalmic suspension 0.6%	Drug: Besivance; Ocular administration to affected eye for 7 days
Placebo Comparator: Vehicle; Vehicle of Besivance	Drug: Vehicle; Vehicle of Besivance administered to affected eye for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Treatment Emergent Adverse Events	Ocular Treatment-Emergent Adverse Events on the Study Eye	At each visit - 7 days
Non-Ocular Treatment-Emergent Adverse Events	Non-Ocular Treatment-Emergent Adverse Events on the Study Eye	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Resolution	The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data	Day 8 (Visit 2)
Clinical Resolution	The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.	Day 11 (Visit 3)
Microbial Eradication	The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.	Days 8 (Visit 2)
Microbial Eradication	The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.	Days 11 (Visit 3)
Microbial Outcome With Clinical Resolution	At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline	Day 8 (Visit 2)
Microbial Outcome With Clinical Resolution	At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline	Day 11 (Visit 3)
Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 1 (Vist 1)
Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 8 (Vist 2)
Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 11 (Vist 3)
Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 1 (Vist 1)
Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 8 (Vist 2)
Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 11 (Vist 3)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Catherine Allaire, MD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 4, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: March 19, 2013
• Last Verified: March 1, 2013

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: 631