Determining the Role of Synthetic Cannabinoids in Eye Pressure And Tolerability Measurements (DREAM)
Research type
Research Study
Full title
Determining the Role of Synthetic Cannabinoids in Eye Pressure And Tolerability Measurements (DREAM). A Pilot, Randomised, Cross-Over Study to Determine the Effects of an Oral, Peripherally Selective, Synthetic Cannabinoid ART27.13 on Intraocular Pressure
IRAS ID
1010931
Contact name
Augusto Azuara-Blanco
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
ISRCTN Number
ISRCTN10996483
Research summary
Glaucoma is a leading cause of irreversible blindness. There are currently no treatments that cure glaucoma; however, medications that reduce intraocular pressure (IOP) may slow or prevent disease progression. Evidence suggests that cannabinoids effectively reduce IOP however their side effects are often difficult to tolerate. ART27.13 is a synthetic cannabinoid, previous clinical studies have shown that it is safe and well-tolerated, and may provide an alternative to currently licenced glaucoma medications. There is a need for better treatments in glaucoma, and this project will address the top research priority by James Lind Alliance. This study can facilitate the development and future use of effective and safe oral medications for glaucoma.
The study aims to assess the efficacy and safety of ART27.13, given orally, to reduce IOP in patients with ocular hypertension or early primary open angle glaucoma. This is a randomized, double-masked, placebo-controlled, single-site, crossover study. The study will take place within the Hospital Eye Services and is funded by Glaucoma UK and the Public Health Agency (PHA), Health and Social Care (HSC) Research & Development Division, Northern Ireland. The study is expected to run for 18months in total. It will involve participants taking medication daily, there will be phone call follow-ups on week 1, 7 and 13 along with onsite visits on baseline and weeks 3, 6 and 9.
Ten patients over 40 years of age with ocular hypertension or early primary open angle glaucoma and an IOP of between 20 and 35 mmHg (inclusive) will be recruited. Patients will be randomised to ART27.13 (600 microgram once daily) or placebo for 3 weeks. After 3 weeks of treatment the patients will complete a 3 week wash out period then the patients will cross over and receive the alternative treatment for another 3 weeks. The main outcome measures is IOP. Secondary outcomes include tolerability and safety
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0218
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion