Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Research type
Research Study
Full title
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients with Open Angle Glaucoma or Ocular Hypertension
IRAS ID
267131
Contact name
Rupert Bourne
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2018-003597-26
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Glaucoma is a condition which can affect sight, usually due to build-up of pressure within the eye (high intraocular pressure (IOP)). Glaucoma can be treated with eye drops, laser treatment or surgery, each of which has its own risk. Patient non- compliance using eye drops can be a problem treating high IOP.
The Bimatoprost SR (sustained release) formulation is a 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 24 months.
The purpose of this study is to look into the safety and duration of effect of two dose strengths of Bimatoprost SR in the treatment of glaucoma or ocular hypertension (high eye pressure).
The total number of study visits will depend on whether the participant receives additional Bimatoprost SR administrations or not. If eligible, the participant may receive up to 2 Bimatoprost SR administrations in their study eye, as needed. The study doctor will advise whether or not a participant is eligible to receive Bimatoprost SR during this study, depending on what previous Bimatoprost SR study they participated in and the study doctor’s clinical judgment. The additional administrations will be of the same dose strength previously received during the lead-in study. In the other eye (fellow eye) the study doctor will decide the most appropriate treatment.
The duration of the study for each participant is approximately 24 months, depending on whether or not they receive additional Bimatoprost SR administrations.
Approximately 600 participants will take part in the study worldwide with 20 participants in the UK.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0282
Date of REC Opinion
7 Nov 2019
REC opinion
Further Information Favourable Opinion