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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00347932
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011

June 30, 2006
December 7, 2011
June 2006
November 2007   (final data collection date for primary outcome measure)
  • Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 5 +/- 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00347932 on ClinicalTrials.gov Archive Site
  • Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 8 or 9 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.
A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acute Bacterial Conjunctivitis
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
957
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00347932
433, BOL-303224
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Laura Trusso Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
December 2011

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