Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT01010633|
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : January 9, 2012
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Pain||Drug: Vehicle of Loteprednol Etabonate Drug: Loteprednol Etabonate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2010|
Experimental: Loteprednol Etabonate
Drug: Loteprednol Etabonate
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Placebo Comparator: Vehicle
Vehicle of loteprednol etabonate
Drug: Vehicle of Loteprednol Etabonate
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
- Resolution of Anterior Chamber Cells (ACC). [ Time Frame: Visit 5 (Postoperative day 8) ]Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
- Grade 0 Pain [ Time Frame: Visit 5 (Postoperative Day 8) ]Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
- Resolution of Anterior Chamber Cells. [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ]Study eyes with complete resolution of anterior chamber cells (ACC)
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): NCT01010633
|United States, New York|
|Bausch & Lomb, Inc.|
|Rochester, New York, United States, 14609|
|Study Director:||Laura Trusso||Bausch & Lomb Incorporated|