Bimatoprost SR in Open-angle Glaucoma or Ocular Hypertension
Research type
Research Study
Full title
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
IRAS ID
169126
Contact name
Francesca Cordeiro
Contact email
Sponsor organisation
Allergan Ltd
Eudract number
2014-003186-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The Bimatoprost SR (sustained release) formulation is very small biodegradable, preservative-free implant preloaded into a single use applicator which does not require patient self-administration. Bimatoprost is the same active ingredient as the commercially approved LUMIGAN® eye drops.
Bimatoprost SR is placed inside the eye between the cornea and the iris. Once placed, the drug is slowly released for about 3 to 4 months and the implant slowly dissolves in about 12 to 15 months. As of April, 2014, a total of 87 patients had received a single administration and of those, 12 had received a repeat administration of Bimatoprost SR on the 192024-041D study. There were no serious ocular adverse events, no implants had to be removed. The most frequently reported adverse events were mild in severity, occurred within the first days after Bimatoprost SR administration, and were considered related to the study drug administration procedure.
This study investigates the safety and effectiveness of two different dose strengths (10 µg or 15 µg) of Bimatoprost SR compared to treatment with Timolol 0.5% eye drops in lowering eye pressure in patients with glaucoma or high eye-pressure. Timolol 0.5% is an approved drug for lowering eye pressure. The study duration is 22 months for each patient consisting of screening, washout, 52-week treatment period, plus 8 months extended follow up. Patients will be randomly assigned to one of the three treatment groups and will receive Bimatoprost SR or Control treatment (Timolol eye drops plus Sham needleless procedure) on Day 1 with repeat administration of the same dose strength or Sham at Week 16 and Week 32. Patients who complete the entire study will have a minimum of 25 visits and 6 phone calls. Patients may also voluntarily withdraw from the study at any time
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0141
Date of REC Opinion
23 Apr 2015
REC opinion
Further Information Favourable Opinion