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

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Bacterial Conjunctivitis

Treatments

Drug: Besivance

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

631

Details and patient eligibility

About

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

Enrollment

518 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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.