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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175590
• Other study ID #: 631
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2010
• Last updated: March 19, 2013
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Besivance
Ocular administration to affected eye for 7 days
• Vehicle
Vehicle of Besivance administered to affected eye for 7 days

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc.	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	Ocular Treatment Emergent Adverse Events	Ocular Treatment-Emergent Adverse Events on the Study Eye	At each visit - 7 days	No
Primary	Non-Ocular Treatment-Emergent Adverse Events	Non-Ocular Treatment-Emergent Adverse Events on the Study Eye	7 days	No
Secondary	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)	No
Secondary	Clinical Resolution	The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.	Day 11 (Visit 3)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 1 (Vist 1)	No
Secondary	Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 8 (Vist 2)	No
Secondary	Individual Clinical Outcomes - Ocular Discharge	ocular conjunctival discharge measured as absent, mild, moderate or severe	At day 11 (Vist 3)	No
Secondary	Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 1 (Vist 1)	No
Secondary	Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 8 (Vist 2)	No
Secondary	Individual Clinical Outcomes - Bulbar Injection	Bulbar conjunctival injection measured as normal, mild, moderate or severe	At day 11 (Vist 3)	No