Duration of effect of Bimatoprost SR in participants with OAG or OHT

  • Research type

    Research Study

  • Full title

    A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension

  • IRAS ID

    261137

  • Contact name

    Vincent Dubois

  • Contact email

    vincent.dubois@aintree.nhs.uk

  • Sponsor organisation

    Allergan Ltd.

  • Eudract number

    2018-002574-52

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT03850782

  • Duration of Study in the UK

    3 years, 4 months, 28 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 15 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).

    Participants will be randomised using a 1:1 ratio. Depending on what treatment group the participant is assigned to, they will either receive one of two dose strengths of Bimatoprost SR in one of the eyes (study eye) and 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 32 months consisting of a screening period of up to 10 days before washout, washout period of up to 42 days before the initial Bimatoprost SR administration, 18-month PRN (as needed) treatment period, plus at least 12 months of extended follow up.

    Approximately 300 participants will take part in the study worldwide with 16 participants in the UK.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    19/EM/0188

  • Date of REC Opinion

    1 Aug 2019

  • REC opinion

    Further Information Favourable Opinion