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

Last updated: March 4, 2015
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Conjunctivitis, Bacterial

Eye Disorders/infections

Allergy

Treatment

N/A

Clinical Study ID

NCT00347932
433
BOL-303224
  • Ages > 1
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulentconjunctival discharge and redness in at least one eye.

  • Females of childbearing potential must utilized reliable contraceptive methods andhave a negative pregnancy test.

Exclusion

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 evaluationsof the study medications.

  • Participation in an ophthalmic drug or device research study within 30 days prior toentry into the study.

Study Design

Total Participants: 957
Study Start date:
June 01, 2006
Estimated Completion Date:
November 30, 2007