B&L577 LE Next Gen
Research type
Research Study
Full title
A Randomized, Multicenter, Double - Masked, Parallel- Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Opthalmic Gel, 0.5 % versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery.
IRAS ID
52737
Contact name
P Bloom
Sponsor organisation
Dr Gerhard Mann chem.-pharm. Fabrik GmbH/Bausch & Lomb
Eudract number
2010-019246-11
ISRCTN Number
NCT01060072
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate the safety and effectiveness of the corticosteroid Loteprednol Etabonate (LE) Ophthalmic Gel 0.5 % compared to that of an eye gel without the active ingredient in treating eye inflammation and pain following cataract surgery. The active substance in the product is LE which has been approved by the responsible health authorities in the USA and in Europe for use in treating eye inflammation. The difference between the product already registered (Lotemax© 0.5% Eye Drops) and the product being tested is in the formulation: that's, the inactive substances used as carriers for the active ingredients differ in the eye drops formula. This new formulation of LE Ophthalmic Gel 0.5 % is expected to be more effective in preventing and reducing inflammation after eye surgery. Study population compromises patients that are scheduled to undergo routine cataract surgery. Approximately 400 patients will be enrolled across 20 US centres and 4 EU centres. In the UK there will be 2 centres; each will recruit a maximum of 20 patients. This is a double-masked study meaning neither the subject nor the study doctor will know which treatment is being given. Approximately 200 patients will be randomized (chosen by chance) to receive study drug and 200 to receive vehicle. Patients’ participation in the study will last about 4 weeks from the screening visit (Visit 1 ?? 14 days prior to surgery) to the last visit (Visit 7). At each visit eye examinations that are part of routine clinical practice will be performed by the study doctor. Visit 2 will be the day of surgery. The day after surgery (Visit 3), the study doctor will assess whether the patient can be included into the study or not. Suitable patients will receive the initial dose of the study drug and instructions on how to use the eye-drops at home. Thereafter patients will complete study visits 4-7 administering 1 or 2 drops of the study drug in the study eye, 4 times daily at approximately 4 hour intervals. Study treatment period will last approximately 14 days, with last administration on the fourth dose day before Visit 6.
REC name
London - Harrow Research Ethics Committee
REC reference
10/H0709/50
Date of REC Opinion
15 Jul 2010
REC opinion
Further Information Favourable Opinion