Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Completed · Phase 3
Conditions studied: Bacterial Conjunctivitis
In brief
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Key facts
- Study ID
- NCT01175590
- Run by
- Bausch & Lomb Incorporated
- People needed
- 518
- Starts
- 2010-06-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2013-05-01
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Bausch & Lomb, Inc. — Rochester, New York, United States
Full record on ClinicalTrials.gov
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