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

NCT01740388 | Terminated Phase 3 Results

• 1 other identifier: 801
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Clinical Resolution

  Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%

  Visit 2 (Day 4 or 5)

• Microbial Eradication

  Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%

  Visit 2 (Day 4 or 5)

Secondary Outcomes (2)

• Clinical Resolution

  Visit 3 (Day 6, 7, or 8)

• Microbial Eradication

  Visit 3 (Day 6, 7, or 8)

Other Outcomes (2)

• Ocular Conjunctival Discharge

  At each follow-up visit (Visit 1, Visit 2 and Visit 3)

• Bulbar Conjunctival Injection

  At each follow-up visit (Visit 1, Visit 2 and Visit 3)

Study Arms (2)

Besifloxacin

EXPERIMENTAL

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

Drug: Besifloxacin

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

Besifloxacin DRUG

one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.

Also known as: Besivance

Besifloxacin

Vehicle DRUG

one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.

Vehicle

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

besifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Johnson Varughese
• Organization: Valeant Pharmaceuticals

Johnson.Varughese@valeant.com

908-541-2179

Study Officials

• Johnson Varughese

  Valeant Pharmaceuticals/Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 4, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 1, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

US (1)