Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
|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|
|Primary Completion Date :||June 2010|
|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)
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|