Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00347932
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : August 13, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Results First Submitted Date  ICMJE June 29, 2009
Results First Posted Date  ICMJE August 13, 2009
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE June 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
  • Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 5 +/- 1 day ]
    The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
  • Microbial Eradication of Baseline Bacterial Infection [ Time Frame: Day 5 +/- 1 day ]
    Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00347932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
  • Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 8 or 9 ]
    The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
  • Microbial Eradication of Baseline Bacterial Infection [ Time Frame: Day 8 or 9 ]
    Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
Official Title  ICMJE A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Brief Summary Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
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 Acute Bacterial Conjunctivitis
Intervention  ICMJE
  • Drug: ISV-403
    Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
    Other Names:
    • besifloxacin
    • Besivance
    • BOL-303224
  • Drug: Vehicle
    Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.
Study Arms  ICMJE
  • Experimental: ISV-403
    0.6% ISV-403 ophthalmic suspension
    Intervention: Drug: ISV-403
  • Placebo Comparator: Vehicle
    Vehicle of ISV-403 ophthalmic suspension
    Intervention: Drug: Vehicle
Publications *

*   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: February 19, 2008)
957
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
  • Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
  • Use of any antibiotic within 72 hours of treatment.
  • Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
  • Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00347932
Other Study ID Numbers  ICMJE 433
BOL-303224 ( Registry Identifier: CAS )
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: Laura Trusso Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date March 2015

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