Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
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|ClinicalTrials.gov Identifier: NCT00972777|
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Conjunctivitis||Drug: Besifloxacin Drug: Vehicle (Placebo)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||474 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||February 2011|
0.6% ophthalmic suspension
Besifloxacin 0.6% administered into the study eye two times a day for three days.
Other Name: Besivance
|Placebo Comparator: Vehicle||
Drug: Vehicle (Placebo)
Vehicle administered to the study eye two times a day for three days.
- Clinical Resolution [ Time Frame: Visit 2 ]The absence of both conjunctival discharge and bulbar conjunctival injection.
- Microbial Eradication [ Time Frame: Visit 2 ]The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
- Clinical Resolution [ Time Frame: Visit 3 ]The absence of both conjunctival discharge and bulbar conjunctival injection.
- Microbial Eradication [ Time Frame: Visit 3 ]The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
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): NCT00972777
|United States, New York|
|Bausch & Lomb Incorporated|
|Rochester, New York, United States, 14609|
|Study Director:||Michael R Paterno, OD||Bausch & Lomb Incorporated|