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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Conjunctival Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Infection
Besifloxacin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014