RecruitingPhase IIInterventional

Determining the role of synthetic cannabinoids in eye pressure and tolerability measurements

This study is looking into a new medication called ART27.13, which is a type of synthetic cannabinoid. It aims to see if ART27.13 can safely reduce pressure inside the eye for people with high eye pressure or early glaucoma. Glaucoma is a condition that can gradually damage your eyesight, and lowering eye pressure is a way to help slow its progress. Other similar medications have been tested, but often cause unwanted side effects like feeling sick or dizzy. ART27.13 is designed to work differently, hopefully avoiding these problems. This study will involve men aged 40 or older, and women aged 55 or older, and will compare ART27.13 to a dummy pill to see if it works and is well-tolerated.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Belfast Health and Social Care Trust

Enrolment target

Start

29 May 2026

Estimated completion

30 Oct 2026

Ocular hypertension or early primary open angle glaucoma

What is this study about?

Glaucoma is a group of eye conditions that can lead to permanent vision loss. It often happens when the pressure inside your eye gets too high, which can damage the delicate nerve that connects your eye to your brain. While there’s no cure for glaucoma, treatments that lower this eye pressure can help prevent the condition from getting worse. Scientists have looked at drugs similar to cannabis (called cannabinoids) in the past, and some have shown promise in reducing eye pressure. However, these often came with side effects like feeling sick, confused, or dizzy, which made them difficult for people to use.

This new study is focusing on a drug called ART27.13. It's also a synthetic cannabinoid, but it's designed to work mainly in the eye and not affect the brain as much. The hope is that ART27.13 will be able to lower eye pressure effectively without causing those uncomfortable side effects. By testing this, we aim to find a better, more tolerable treatment option for people with high eye pressure or early glaucoma.

We need to understand how safe ART27.13 is, how well people can tolerate it, and if it truly lowers eye pressure. This information is crucial for developing new and improved ways to manage glaucoma and protect people's vision in the future.

Key takeaways

This study tests a new drug (ART27.13) for high eye pressure or early glaucoma.
The goal is to see if ART27.13 lowers eye pressure safely, without strong side effects.
Participants will take either ART27.13 or a dummy pill for three-week periods.
Regular health checks, eye exams, and phone calls will monitor your progress.
Possible side effects include dizziness, nausea, and changes in blood tests.
You can stop participating at any time.

Who may be eligible?

This study is looking for men who are 40 years old or older, and women who are 55 years old or older. You need to have either high pressure in your eyes (called ocular hypertension) or early-stage glaucoma. Your eye pressure should be between 20 and 35 units.

There are also some reasons why you might not be able to join. For example, if you have other serious eye conditions, or certain liver, kidney, or heart problems. If you've had recent eye surgery or laser treatment for glaucoma, or if you've been diagnosed with certain types of cancer lately, you might not be eligible. We also can't include women who could become pregnant, or men whose partners aren't using contraception during the study.

Additionally, if you've used certain cannabis-based products for other reasons recently (except for CBD), or if you're taking specific medications that interact with the study drug, you wouldn't be able to participate. The research team will review all your health information carefully to make sure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 40 or over, or a woman aged 55 or over?
Do you have high eye pressure or early glaucoma?
Do you have any other serious eye conditions?
Have you had recent eye surgery or laser treatment for glaucoma?
Are you taking any medications that might interact with the study drug?
Are you currently pregnant or could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for several months. Before starting any treatment, you'll have an initial visit with blood tests, a general health check, and eye exams. If you’re already using eye drops for glaucoma, you’ll need to stop them for four weeks before starting the study and throughout the study.

The study involves two main treatment periods. You'll either receive the new drug ART27.13 or a dummy pill (placebo) for three weeks. After a three-week break without any treatment, you'll then switch to the other treatment for another three weeks. The pills look identical so neither you nor the study team will know what you are taking at any given time. Throughout these periods, you'll have phone calls with the research team to check how you're feeling, and clinic visits after each three-week treatment period for blood tests, health checks, eye exams, and to fill out questionnaires. There will also be a final check-up phone call four weeks after your last clinic visit.

Potential risks and benefits

Taking part in a new research study can be very important for finding better ways to treat diseases like glaucoma. However, because ART27.13 is a new treatment, we don't know for sure how it will affect everyone. You might experience side effects such as increased eye pressure, dizziness (especially when standing up), feeling sick, low blood pressure, headaches, dry mouth, tiredness, drowsiness, back pain, or generally feeling unwell. There could also be changes in your liver blood tests. ART27.13 might also make you feel hungrier and potentially lead to weight gain. If you experience dizziness or drowsiness, it's very important not to drive or operate heavy machinery, especially in the first four weeks of taking the medication each time. You are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northern Ireland Clinical Research Facility
City only
Belfast, Northern Ireland

Common questions

What is glaucoma?

Glaucoma is an eye condition that can damage your eyesight, often due to high pressure inside your eye damaging the optic nerve.

What is ART27.13?

ART27.13 is a new type of medication, similar to cannabis but designed to mostly affect the eye and potentially lower eye pressure without strong side effects.

Will I know if I'm taking the study drug or a dummy pill?

No, neither you nor the study team will know whether you are taking ART27.13 or the dummy pill; this is to ensure the study results are fair.

Where is the study taking place?

The study is being run from the Northern Ireland Clinical Research Facility (NICRF) at Belfast City Hospital.

Who is paying for this research?

The study is funded by Glaucoma UK and the Public Health Agency (PHA), Health and Social Care (HSC) Research & Development Division in Northern Ireland.

How to find out more

Megan Campbell

DREAM@nictu.hscni.net +44 2896151447 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.