Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00905762|
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : December 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Gatifloxacin Drug: Moxifloxacin Drug: Besifloxacin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Besifloxacin one drop instilled into study eye.
Besifloxacin 0.6% one drop instilled into study eye at visit 2.
Other Name: Besivance
Active Comparator: Gatifloxacin
Gatifloxacin one drop instilled into study eye.
Gatifloxacin 0.3% one drop instilled into study eye at visit 2.
Active Comparator: Moxifloxacin
Moxifloxacin one drop instilled into study eye.
Moxifloxacin 0.5% one drop instilled into study eye at visit 2.
- Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue. [ Time Frame: Biopsies collected at specified time points from 15 minutes to 24 hours ]
- Visual acuity [ Time Frame: Day -14 through Day 6(+/-1) ]
- Slit Lamp Biomicroscopy [ Time Frame: Day -14 through Day 6 (+/-) ]
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): NCT00905762
|United States, New York|
|Bausch & Lomb Incorporated|
|Rochester, New York, United States, 14609|
|Study Director:||Timothy Comstock, OD||Bausch & Lomb Incorporated|