Status:
COMPLETED
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT01175590
Start Date
June 1 2010
End Date
February 1 2012
Last Update
May 1 2013
Active Locations (1)
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1
Bausch & Lomb, Inc.
Rochester, New York, United States, 14609