Determining the role of synthetic cannabinoids in eye pressure and tolerability measurements
| ISRCTN | ISRCTN10996483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10996483 |
| Integrated Research Application System (IRAS) | 1010931 |
| Sponsor | Belfast Health and Social Care Trust |
| Funders | Glaucoma UK, Public Health Agency (PHA), Health and Social Care (HSC) Research & Development Division, Northern Ireland |
- Submission date
- 31/03/2026
- Registration date
- 01/04/2026
- Last edited
- 29/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a leading cause of irreversible blindness. The term ‘glaucoma’ refers to a group of heterogenous pathologies that result in excavation of the eye, progressive damage to the retinal ganglion cells (RGCs), optic nerve damage, and subsequent visual impairment. There are currently no treatments that cure glaucoma; however, medications that reduce intraocular pressure (IOP) may slow or prevent disease progression. There have been several clinical studies that have assessed synthetic cannabinoids on glaucoma. Many of these have shown significant lowering of IOP however the effects can be short lived and the drugs have been shown to cause side effects that patients were not able to tolerate including nausea, confusion, euphoria and dizziness.
ART27.13 is a synthetic, peripherally selective cannabinoid with minimal brain penetration therefore it should not cause the unwanted side effects seen in other cannabinoids. This trial will investigate the safety and tolerability of treatment with capsulated ART27.13 at a dose of 600ug over a three week treatment period and whether is reduces IOP.
Who can participate?
Males aged 40 years or older and females aged 55 years or older with ocular hypertension or early primary open angle glaucoma.
What does the study involve?
Any participant who is already on topical glaucoma treatment will undergo a four-week wash out period before baseline and will not use any glaucoma drops during the trial. The study will run as a crossover design in which one half of the recruited participants will be randomised to receive ART27.13 or placebo for three weeks. Following this, patients who initially received ART27.13 will then be switched to placebo for three weeks (and vice versa) following a three-week washout period. This design was chosen to maximise the efficiency of the study, ensuring that data on ART27.13 is acquired from all study participants. The placebo will be in capsule form, identical in appearance to ART27.13, to minimise the risk of bias.
Participants will have screening and baseline tests done before receiving any treatment including blood tests, physical exam and eye exams. One week after receiving the first treatment (either ART27.13 or placebo), the research staff will phone the participant to ask questions around how they are feeling. Participants will come back to the clinic after the three weeks of treatment where they will complete a questionnaire and have bloods taken along with a physical exam and eye exams to measure IOP. After a three week wash out with no treatment, participants will come back to the clinic to have more tests and receive their second treatment (either placebo or ART27.13). Another phone call will be made by research staff one week after starting the second treatment. Participants will come back to clinic after three weeks of the second treatment to have post-treatment tests carried out including blood tests, physical exam and eye exams. A final phone call check up will be made 4 weeks after the clinic visit.
What are the possible benefits and risks of participating?
New research is vital to developing new treatments for diseases, especially for glaucoma. However, as this is a new
treatment we cannot be certain of the outcome and participants may experience side effects such as; increased IOP, dizziness, postural dizziness, nausea, low blood pressure (hypotension), headache, dry mouth, fatigue, drowsiness (somnolence), back pain, malaise, and changes in blood tests looking at liver function. ART27.13 may also stimulate appetite and lead to weight gain. As side effects of ART27.13 include dizziness and somnolence caution should be taken around driving or operating heavy machinery. Participants cannot drive or operate heavy machinery in the first 4 weeks each time of start taking the medication.
Where is the study run from?
Northern Ireland Clinical Research Facility (NICRF), Belfast City Hospital
When is the study starting and how long is it expected to run for?
April 2026 to May 2027
Who is funding the study?
Glaucoma UK and Public Health Agency (PHA), Health and Social Care (HSC) Research & Development Division, Northern Ireland
Who is the main contact?
Professor Augusto Azuara-Blanco (a.azuara-blanco@qub.ac.uk)
Dr Megan Campbell (DREAM@nictu.hscni.net)
Contact information
Public
7 Lennoxvale
Belfast
BT9 5BY
United Kingdom
| Phone | +44 2896151447 |
|---|---|
| DREAM@nictu.hscni.net |
Scientific, Principal investigator
Institute of Clinical Sciences-A
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
| Phone | +44 28 90976350 |
|---|---|
| a.azuara-blanco@qub.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Crossover |
| Purpose | Treatment |
| Scientific title | A pilot, randomised, cross-over study to determine the effects of an oral, peripherally selective, synthetic cannabinoid ART27.13 on intraocular pressure |
| Study acronym | DREAM |
| Study objectives | 1. To evaluate the IOP lowering efficacy of ART27.13 2. To assess the safety and tolerability of ART27.13 |
| Ethics approval(s) |
Approved 05/02/2026, North East – Newcastle and North Tyneside 2 (2 Redman Place, Stratford, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 104 8086; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 25/NE/0218 |
| Health condition(s) or problem(s) studied | Ocular hypertension or early primary open angle glaucoma |
| Intervention | The investigational medicinal product (IMP) will be ART27.13, a synthetic, peripherally selective cannabinoid which is under development by Artelo Biosciences. The study will run as a crossover design in which one half of the recruited participants will be randomised to receive ART27.13 or placebo for three weeks. Following this, patients who initially received ART27.13 will then be switched to placebo for three weeks (and vice versa) following a three-week washout period. This design was chosen to maximise the efficiency of the study, ensuring that data on ART27.13 is acquired from all study participants. The placebo will be in capsule form, identical in appearance to ART27.13, to minimise the risk of bias. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | ART27.13 |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 28/05/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 1. Age ≥ 40 years for males, ≥ 55 years for females 2. Ocular hypertension or early primary open angle glaucoma (visual field loss, less severe than - 6 dB in a standard 24-2 Humphrey visual field test) 3. IOP between 20 and 35 mmHg inclusive |
| Key exclusion criteria | 1. Any other clinically significant ocular disease in either eye 2. Current liver disease or laboratory results with elevated levels of liver transaminases (AST or ALT >3 x upper limit of normal (ULN) at screening visit) 3. Renal failure (eGFR <30 mL/min/1.73m² at screening visit) 4. Heart disease (e.g. myocardial infarction or arrhythmia) 5. Diagnosed with cancer in the last 12 months (with exception of non-melanoma skin cancer) 6. Prior ocular laser treatment within previous 12 months of enrolment 7. Prior surgical treatment for glaucoma 8. Intraocular surgery within previous 12 months of enrolment 9. Use of cannabinoids for other purposes within 3 months of enrolment (with the exception of cannabidiol (CBD)) 10. Woman of childbearing potential i.e has had a menstrual cycle in the last 12 months or has not been permanently sterilised. 11. Male participants with sexual partners who have not agreed to use a condom during treatment and for 1 month after the last dose is administered. 12. Current use of systemic beta-blockers 13. Within 4 weeks prior to enrolment been on or expected to be on medications that are known to be strong cytochrome P450 CYP3A4 inhibitors or inducers 14. Within 4 weeks prior to enrolment been on or expected to be on medications that are known to be P-glycoprotein (PgP) Inhibitors or Substrates 15. Any clinical condition that, in the investigator’s opinion, would make the participant unsuitable for the trial 16. Non-English speaking patients or those who do not adequately understand verbal or written information 17. Any known allergy to the active ingredient or excipients 18. History of any recreational or illicit drug use, alcohol misuse, or other drug misuse within the last 24 months. 19. Any history of depression in the last five years or current use of anti-depressant medication. 20. Not agreed to abstain from driving or operating heavy machinery for the first 4 weeks of each treatment cycle or longer if AEs warrant. 21. Total serum Bilirubin > 1.5 x upper limit of normal 22. Any history of suicidal behaviour or serious suicidal ideation, defined as Category 4 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening. 23. Declined consent |
| Date of first enrolment | 29/05/2026 |
| Date of final enrolment | 30/10/2026 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Lisburn Road
Belfast
BT9 7AB
Northern Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/04/2026: The following changes were made to the study record:
1. The Completion date was changed from 29/04/2027 to 28/05/2027.
2. The Date of first enrolment was changed from 30/04/2026 to 29/05/2026.
3. The Date of final enrolment was changed from 30/09/2026 to 30/10/2026.
31/03/2026: Trial's existence confirmed by North East – Newcastle and North Tyneside 2 REC.
