Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The GOBLET trial: A clinical trial on GOblet cell density after Benzalkonium chloride and preservative-free Latanoprost Eye drop Treatment

The GOBLET study is investigating how two common eye drop treatments for high eye pressure (ocular hypertension) and a type of glaucoma (primary open-angle glaucoma) affect the surface of your eye. Specifically, it's looking at special cells called 'goblet cells,' which are important for keeping your eyes moist and healthy. One set of drops contains a preservative called Benzalkonium chloride, while the other does not. By comparing how these drops change the number of goblet cells, and also looking at things like eye pressure, eye dryness, and discomfort, researchers hope to find out which treatment might be better for your eye health and comfort in the long run. This is a Phase IV trial, meaning the medicines are already approved and widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rigshospitalet

Enrolment target

Start

19 Mar 2024

Ocular hypertension Primary open angle glaucoma

What is this study about?

This study, called the GOBLET trial, is looking at how two different types of eye drops used to treat glaucoma and high pressure in the eye affect the front surface of your eye. You might be familiar with eye drops for these conditions, and this study aims to understand a bit more about how they work in the long term.

Specifically, researchers are interested in something called 'goblet cells.' These are very tiny, important cells on the surface of your eye that help make mucus, which is a key part of your tears. This mucus helps keep your eyes moist, healthy, and comfortable. Some eye drops contain preservatives, and doctors want to know if these preservatives might affect these important goblet cells compared to eye drops that don't have preservatives.

The main goal is to see if there's a difference in the number of goblet cells after using one type of eye drop versus another. They will also look at other things like your eye pressure, how dry your eyes feel (using special scores), and the amount of certain substances in your tears. The hope is that the study will help doctors choose eye drops that are not only effective at controlling eye pressure but also gentle on your eyes, improving your comfort and overall eye health.

Key takeaways

The study compares two common eye drops for glaucoma and high eye pressure.
It focuses on how these drops affect special 'goblet cells' on the eye's surface.
One eye drop contains a preservative, the other doesn't.
The goal is to find out which treatment is gentler on the eyes and improves comfort.
Participation involves regular clinic visits and eye assessments.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered.

Both men and women are welcome to participate. The study is specifically for individuals who have been diagnosed with either high pressure in their eyes (called ocular hypertension) or a common type of glaucoma known as primary open-angle glaucoma.

Further specific health checks will be done by the study team to make sure it's safe and appropriate for you to take part. This often includes looking at your other medical conditions and any other medications you might be taking.

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 18 years old or older?
Do you have high eye pressure (ocular hypertension) or a type of glaucoma called primary open-angle glaucoma?
Are you in good general health (as determined by the study doctors)?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be continuing treatment with one of the two eye drop types (either Monoprost or Xalatan) as prescribed by the study doctors. You would have regular visits to the clinic, where the research team would perform various assessments. These assessments would likely include checks of your eye pressure, tests to look at the surface of your eye (like eye staining), and collecting small samples of your tears to measure certain substances. You might also be asked to fill out questionnaires about how your eyes feel (e.g., OSDI score for dryness). The total duration of your participation would involve a series of these visits and assessments over time, though the exact number and frequency are not specified here. You would be given instructions on how and when to use your eye drops, and the study team would monitor your progress.

Potential risks and benefits

Participating in this study means you would receive one of two already approved and commonly used eye drops. A potential benefit is contributing to medical knowledge that could lead to more comfortable and effective treatments for others in the future. For you, it might mean closer monitoring of your eye condition. Potential risks are generally low, as the medications are widely used, but could include side effects commonly associated with these eye drops, such as temporary stinging, redness, or changes in eye colour, or discomfort from the eye tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

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Unverified
Denmark

Common questions

What are goblet cells and why are they important?

Goblet cells are tiny cells on the surface of your eyes that help make mucus. This mucus mixes with your tears to keep your eyes moist, healthy, and comfortable.

What is the difference between the two eye drops being studied?

Both eye drops treat similar eye conditions. The main difference the study is looking at is whether one contains a common preservative called Benzalkonium chloride, while the other is preservative-free.

Will I know which eye drop I am receiving?

The information provided doesn't specify if this is a 'blinded' study, meaning whether you or your doctor would know which specific eye drop you are receiving. This is something important to ask the study team.

What is 'Phase IV' mean for a clinical trial?

Phase IV means the medication is already approved and available to the general public. This phase looks at the treatment over a longer time, often comparing it to other treatments or looking at its effects in real-world use.

How long will I need to be in the study?

The information doesn't state the exact duration, but clinical trials usually involve a number of visits over several months or even longer. The study team will provide you with a clear timeline.