B&L 637 Study
Research type
Research Study
Full title
A Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Multicenter, Exploratory Study Assessing Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
IRAS ID
57300
Contact name
Harminder Dua
Sponsor organisation
Dr. Gerhard Mann, chem.-pharm. Fabrik GmbH/Bausch & Lomb
Eudract number
2010-018441-61
Clinicaltrials.gov Identifier
Research summary
Dry eye is a common, multifactorial condition of the tears and eye surface where inflammation is thought to be an important component. The purpose of this study is to evaluate the best safety and efficacy profile of BOL-303242-X in treating dry eye syndrome. BOL-303242-X is a novel glucocorticoid receptor ligand that may offer powerful anti-inflammatory effect while limiting the side effects typically observed with traditional glucocorticoids, like increased eye pressure after prolonged medication use. This may provide safer treatment options for patients suffering from dry eye. Study population compromises patients suffering from dry eye symptoms for minimum six months and having moderate/severe dry eyes at screening and baseline visit. Approximately 350 patients will be enrolled across 16 US centers and 4 EU centers. In the UK there will be 2 centers and each will recruit a maximum of 20 patients. To identify the best safety and efficacy concentration and daily dosing frequency of BOL-303242-X eye suspension, patients will be randomly assigned to one of 6 treatment groups (5 BOL-303242-X, 1 placebo group). Patients?? participation will last approximately 14 weeks from screening (Visit 1) to last visit (Visit 7). At each visit, eye examinations that are part of routine clinical practice and study specific procedures will be performed, including blood and urine sampling. Eligible patients will receive artificial tear drops to be used up to 4 times a day for the entire duration of the study to prevent significant symptoms in case of insufficient treatment with study medication. After proving eligibility on V2 (baseline) suitable patients will be randomized and receive study medication and the instructions to daily administer a drop from the morning bottle and a drop from the evening bottle in both eyes, starting on that same evening. Study treatment will last approximately 12 weeks, with the last administration on the morning of Visit 7.
REC name
London - South East Research Ethics Committee
REC reference
10/H1102/52
Date of REC Opinion
27 Sep 2010
REC opinion
Further Information Favourable Opinion