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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01175590
First received: August 3, 2010
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: Besivance
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ] [ Designated as safety issue: No ]
    Ocular Treatment-Emergent Adverse Events on the Study Eye

  • Non-Ocular Treatment-Emergent Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Non-Ocular Treatment-Emergent Adverse Events on the Study Eye


Secondary Outcome Measures:
  • Clinical Resolution [ Time Frame: Day 8 (Visit 2) ] [ Designated as safety issue: No ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data

  • Clinical Resolution [ Time Frame: Day 11 (Visit 3) ] [ Designated as safety issue: No ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.

  • Microbial Eradication [ Time Frame: Days 8 (Visit 2) ] [ Designated as safety issue: No ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

  • Microbial Eradication [ Time Frame: Days 11 (Visit 3) ] [ Designated as safety issue: No ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

  • Microbial Outcome With Clinical Resolution [ Time Frame: Day 8 (Visit 2) ] [ Designated as safety issue: No ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline

  • Microbial Outcome With Clinical Resolution [ Time Frame: Day 11 (Visit 3) ] [ Designated as safety issue: No ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline

  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 1 (Vist 1) ] [ Designated as safety issue: No ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 8 (Vist 2) ] [ Designated as safety issue: No ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 11 (Vist 3) ] [ Designated as safety issue: No ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 1 (Vist 1) ] [ Designated as safety issue: No ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe

  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 8 (Vist 2) ] [ Designated as safety issue: No ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe

  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 11 (Vist 3) ] [ Designated as safety issue: No ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe


Enrollment: 518
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besivance
besifloxacin ophthalmic suspension 0.6%
Drug: Besivance
Ocular administration to affected eye for 7 days
Placebo Comparator: Vehicle
Vehicle of Besivance
Drug: Vehicle
Vehicle of Besivance administered to affected eye for 7 days

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175590

Locations
United States, New York
Bausch & Lomb, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Catherine Allaire, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01175590     History of Changes
Other Study ID Numbers: 631
Study First Received: August 3, 2010
Results First Received: February 13, 2013
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014