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

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ClinicalTrials.gov Identifier: NCT01175590
Recruitment Status : Completed
First Posted : August 5, 2010
Results First Posted : May 1, 2013
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Besivance Drug: Vehicle Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2010
Primary Completion Date : December 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Ocular Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ]
    Ocular Treatment-Emergent Adverse Events on the Study Eye

  2. Non-Ocular Treatment-Emergent Adverse Events [ Time Frame: 7 days ]
    Non-Ocular Treatment-Emergent Adverse Events on the Study Eye


Secondary Outcome Measures :
  1. Clinical Resolution [ Time Frame: Day 8 (Visit 2) ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data

  2. Clinical Resolution [ Time Frame: Day 11 (Visit 3) ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.

  3. Microbial Eradication [ Time Frame: Days 8 (Visit 2) ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

  4. Microbial Eradication [ Time Frame: Days 11 (Visit 3) ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.

  5. Microbial Outcome With Clinical Resolution [ Time Frame: Day 8 (Visit 2) ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline

  6. Microbial Outcome With Clinical Resolution [ Time Frame: Day 11 (Visit 3) ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline

  7. Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 1 (Vist 1) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  8. Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 8 (Vist 2) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  9. Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 11 (Vist 3) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe

  10. Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 1 (Vist 1) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe

  11. Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 8 (Vist 2) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe

  12. Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 11 (Vist 3) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe


Eligibility Criteria

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01175590     History of Changes
Other Study ID Numbers: 631
First Posted: August 5, 2010    Key Record Dates
Results First Posted: May 1, 2013
Last Update Posted: May 1, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
Fluoroquinolones
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors