Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis

Bausch + Lomb

Status and phase: Terminated; Phase 3

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Besifloxacin; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740388

801

Details and patient eligibility

About

To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.

Enrollment: 136 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent/purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least 1 eye. A minimum score of 1 should be present for both discharge and for bulbar conjunctival injection.
• Have monocular pin-holed Snellen visual acuity (VA) equal to or better than 20/200 in both eyes. Age appropriate VA testing will be performed. Every effort should be made to obtain a VA measurement in children. If VA is unobtainable in children, it is at the Investigator's discretion to include the subject in the study.
• Be willing to discontinue contact lens wear for the duration of the study.

Exclusion criteria

• Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
• Have a known hypersensitivity or contraindications to besifloxacin, fluoroquinolones, or any of the ingredients in the study drugs.
• Be expected to require treatment with systemic or ocular (either eye) nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, or corticosteroids during the study or have used any of these medications within 2 days prior to study start.
• Be expected to require concurrent ocular therapy in either eye with any ophthalmic solutions (unless specified below), including tear substitutes, during the study or have used any ophthalmic solutions within 2 hours prior to study start. Be expected to require concurrent ocular therapy (either eye) with mast cell stabilizers or decongestants during the study or have used any of the above within 2 days prior to study start.
• Be expected to require concurrent systemic or ocular therapy with immunosuppressants (eg, Restasis) during the study or have used systemic or ocular immunosuppressants within 30 days prior to study start.
• Be expected to require treatment with systemic or ocular (either eye) antibacterials (other than study drug) during the study or have used any systemic or ocular antibacterial within 3 days prior to study start.
• Be likely to require antimicrobial therapy for conditions such as respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media during the study.
• Have had ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
• Have suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
• Have suspected iritis
• Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
• Have any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
• Be immune compromised.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups, including a placebo group

Besifloxacin

Experimental group

Description:

besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Treatment:

Drug: Besifloxacin

Vehicle

Placebo Comparator group

Description:

vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis

Treatment:

Drug: Vehicle