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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):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE August 3, 2010
First Posted Date  ICMJE August 5, 2010
Results First Submitted Date  ICMJE February 13, 2013
Results First Posted Date  ICMJE May 1, 2013
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • Ocular Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ]
    Ocular Treatment-Emergent Adverse Events on the Study Eye
  • Non-Ocular Treatment-Emergent Adverse Events [ Time Frame: 7 days ]
    Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ]
Ocular and non-ocular AEs
Change History Complete list of historical versions of study NCT01175590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • 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
  • Clinical Resolution [ Time Frame: Day 11 (Visit 3) ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
  • 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.
  • 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.
  • 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
  • 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
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 1 (Vist 1) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 8 (Vist 2) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 11 (Vist 3) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 1 (Vist 1) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 8 (Vist 2) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 11 (Vist 3) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
  • Clinical Resolution [ Time Frame: Day 10, 11, or 12 ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
  • Microbial Eradication [ Time Frame: Days 10, 11, or 12 ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
  • Individual clinical outcomes [ Time Frame: At each vist through day 12 ]
    ocular conjunctival discharge bulbar conjunctival injection
  • Microbial outcome and clinical outcome [ Time Frame: At each visit through day 12 ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
  • Visual Acuity [ Time Frame: Each visit through day 12 ]
    Visual acuity will be measured at each visit using a Snellen chart.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Official Title  ICMJE 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
Brief Summary The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Conjunctivitis
Intervention  ICMJE
  • Drug: Besivance
    Ocular administration to affected eye for 7 days
  • Drug: Vehicle
    Vehicle of Besivance administered to affected eye for 7 days
Study Arms  ICMJE
  • Experimental: Besivance
    besifloxacin ophthalmic suspension 0.6%
    Intervention: Drug: Besivance
  • Placebo Comparator: Vehicle
    Vehicle of Besivance
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2013)
518
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2010)
540
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01175590
Other Study ID Numbers  ICMJE 631
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Catherine Allaire, MD Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP