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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
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Bacterial Conjunctivitis
 Drug: ISV-403
Drug: Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 957
Study Start Date: June 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-403
0.6% ISV-403 ophthalmic suspension
 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
Placebo Comparator: Vehicle
Vehicle of ISV-403 ophthalmic suspension
 Drug: Vehicle
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347932

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Laura Trusso Bausch & Lomb Incorporated
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347932     History of Changes
Other Study ID Numbers: 433, BOL-303224
Study First Received: June 30, 2006
Results First Received: June 29, 2009
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
 Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection

ClinicalTrials.gov processed this record on May 16, 2013