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

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

Overview[ - collapse ][ - ]

Purpose	The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Condition	Bacterial Conjunctivitis
Intervention	Drug: Besivance Drug: Vehicle
Phase	Phase 3
Sponsor	Bausch & Lomb Incorporated
Responsible Party	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier	NCT01175590
First Received	August 3, 2010
Last Updated	March 19, 2013
Last verified	March 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 3, 2010
Last Updated Date	March 19, 2013
Start Date	June 2010
Estimated Primary Completion Date	February 2012
Current Primary Outcome Measures	Ocular Treatment Emergent Adverse Events [Time Frame: At each visit - 7 days] [Designated as safety issue: No]Ocular Treatment-Emergent Adverse Events on the Study Eye Non-Ocular Treatment-Emergent Adverse Events [Time Frame: 7 days] [Designated as safety issue: No]Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Current Secondary Outcome Measures	Clinical Resolution [Time Frame: Day 8 (Visit 2)] [Designated as safety issue: No]The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data Clinical Resolution [Time Frame: Day 11 (Visit 3)] [Designated as safety issue: No]The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Microbial Eradication [Time Frame: Days 8 (Visit 2)] [Designated as safety issue: No]The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. Microbial Eradication [Time Frame: Days 11 (Visit 3)] [Designated as safety issue: No]The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. Microbial Outcome With Clinical Resolution [Time Frame: Day 8 (Visit 2)] [Designated as safety issue: No]At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline Microbial Outcome With Clinical Resolution [Time Frame: Day 11 (Visit 3)] [Designated as safety issue: No]At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline Individual Clinical Outcomes - Ocular Discharge [Time Frame: At day 1 (Vist 1)] [Designated as safety issue: No]ocular conjunctival discharge measured as absent, mild, moderate or severe Individual Clinical Outcomes - Ocular Discharge [Time Frame: At day 8 (Vist 2)] [Designated as safety issue: No]ocular conjunctival discharge measured as absent, mild, moderate or severe Individual Clinical Outcomes - Ocular Discharge [Time Frame: At day 11 (Vist 3)] [Designated as safety issue: No]ocular conjunctival discharge measured as absent, mild, moderate or severe Individual Clinical Outcomes - Bulbar Injection [Time Frame: At day 1 (Vist 1)] [Designated as safety issue: No]Bulbar conjunctival injection measured as normal, mild, moderate or severe Individual Clinical Outcomes - Bulbar Injection [Time Frame: At day 8 (Vist 2)] [Designated as safety issue: No]Bulbar conjunctival injection measured as normal, mild, moderate or severe Individual Clinical Outcomes - Bulbar Injection [Time Frame: At day 11 (Vist 3)] [Designated as safety issue: No]Bulbar conjunctival injection measured as normal, mild, moderate or severe

Descriptive Information[ + expand ][ + ]

Brief Title	Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Official Title	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
Brief Summary	The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Bacterial Conjunctivitis
Intervention	Drug: Besivance Ocular administration to affected eye for 7 days Drug: Vehicle Vehicle of Besivance administered to affected eye for 7 days
Study Arm (s)	Experimental: Besivance besifloxacin ophthalmic suspension 0.6% Placebo Comparator: Vehicle Vehicle of Besivance

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	518
Estimated Completion Date	February 2012
Estimated Primary Completion Date	December 2011
Eligibility Criteria	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.
Gender	Both
Ages	1 Year
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01175590
Other Study ID Numbers	631
Has Data Monitoring Committee	No
Information Provided By	Bausch & Lomb Incorporated
Study Sponsor	Bausch & Lomb Incorporated
Collaborators	Not Provided
Investigators	Study Director: Catherine Allaire, MD Bausch & Lomb Incorporated
Verification Date	March 2013

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