A pilot, randomised, cross-over study to determine the effects of an oral, peripherally selective, synthetic cannabinoid ART27.13 on intraocular pressure
Ocular hypertension or early primary open angle glaucoma
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.
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
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 Bili