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 ]
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