Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
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|ClinicalTrials.gov Identifier: NCT01120418|
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : August 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Besifloxacin Ophthalmic Suspension 0.6%||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||February 2008|
Experimental: Besifloxacin Ophthalmic Suspension 0.6%
Topical ocular administration three times daily (TID) for 5 days
Drug: Besifloxacin Ophthalmic Suspension 0.6%
administered 3 times a day for 5 days to one eye.
Other Name: ISV-403
- Endothelial cell density change between treatment group. [ Time Frame: Baseline, 5 days ]Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.
- Endothelial cell density change within treatment group [ Time Frame: Baseline, 5 days ]Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.
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): NCT01120418
|United States, New York|
|Bausch & Lomb|
|Rochester, New York, United States, 14609|
|Study Director:||Laura Trusso, MS||Bausch & Lomb Incorporated|