Clinical Trial: Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

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

Official Title: A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days

Brief Summary: The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Detailed Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome:

  • Ocular Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ]
    Ocular Treatment-Emergent Adverse Events on the Study Eye
  • Non-Ocular Treatment-Emergent Adverse Events [ Time Frame: 7 days ]
    Non-Ocular Treatment-Emergent Adverse Events on the Study Eye


Original Primary Outcome: Treatment Emergent Adverse Events [ Time Frame: At each visit - 7 days ]

Ocular and non-ocular AEs


Current Secondary Outcome:

  • Clinical Resolution [ Time Frame: Day 8 (Visit 2) ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
  • Clinical Resolution [ Time Frame: Day 11 (Visit 3) ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
  • Microbial Eradication [ Time Frame: Days 8 (Visit 2) ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
  • Microbial Eradication [ Time Frame: Days 11 (Visit 3) ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
  • Microbial Outcome With Clinical Resolution [ Time Frame: Day 8 (Visit 2) ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
  • Microbial Outcome With Clinical Resolution [ Time Frame: Day 11 (Visit 3) ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 1 (Vist 1) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 8 (Vist 2) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Ocular Discharge [ Time Frame: At day 11 (Vist 3) ]
    ocular conjunctival discharge measured as absent, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 1 (Vist 1) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 8 (Vist 2) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe
  • Individual Clinical Outcomes - Bulbar Injection [ Time Frame: At day 11 (Vist 3) ]
    Bulbar conjunctival injection measured as normal, mild, moderate or severe


Original Secondary Outcome:

  • Clinical Resolution [ Time Frame: Day 10, 11, or 12 ]
    The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
  • Microbial Eradication [ Time Frame: Days 10, 11, or 12 ]
    The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
  • Individual clinical outcomes [ Time Frame: At each vist through day 12 ]
    ocular conjunctival discharge bulbar conjunctival injection
  • Microbial outcome and clinical outcome [ Time Frame: At each visit through day 12 ]
    At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
  • Visual Acuity [ Time Frame: Each visit through day 12 ]
    Visual acuity will be measured at each visit using a Snellen chart.


Information By: Bausch & Lomb Incorporated

Dates:
Date Received: August 3, 2010
Date Started: June 2010
Date Completion:
Last Updated: March 19, 2013
Last Verified: March 2013