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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:
ClinicalTrials.gov Identifier:
NCT00347932
First Posted: July 4, 2006
Last Update Posted: March 24, 2015
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347932


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

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 ( Registry Identifier: CAS )
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: June 29, 2009
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015

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