Clinical Trial: Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome:

  • Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) [ Time Frame: Visit 3 - day 8 or 9 ]
    Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
  • Eradication of Baseline Pathogens (Day 8 or 9) [ Time Frame: Visit 3 - Day 8 or day 9 ]
    Bacterial species eradication of baseline bacterial infection


Original Primary Outcome: clinical resolution and eradication of baseline bacterial conjunctivitis [ Time Frame: day 8 ]

Current Secondary Outcome:

  • Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) [ Time Frame: Visit 2 - Day 4 (+/- 1 day) ]
    The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
  • Eradication of Baseline Pathogens Day 4 (+/- 1 Day) [ Time Frame: Visit 2 - Day 4 (+/- 1 day) ]
    Bacterial species eradication of baseline bacterial infection


Original Secondary Outcome:

  • Clinical Resolution of Baseline Bacterial Conjunctivitis [ Time Frame: Day 4 ]
  • Eradication of baseline bacterial conjunctivitis [ Time Frame: Day 4 ]
  • Individual signs and symptoms, investigator global ratings, composite endpoint of clinical resolution and eradication of bacterial infection, and microbiological and clinical outcome rates on a 0 to 3 scale. [ Time Frame: Day 8 ]
  • Adverse events, visual acuity changes, biomicroscopy evaluations and ophthalmoscopy [ Time Frame: throughout ]


Information By: Bausch & Lomb Incorporated

Dates:
Date Received: February 14, 2008
Date Started: December 2004
Date Completion:
Last Updated: March 4, 2015
Last Verified: March 2015