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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Besifloxacin; Fluoroquinolones

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.