Not recruiting

Study on Goblet Cell Density in Patients with Ocular Hypertension or Primary Open Angle Glaucoma Using Benzalkonium Chloride and Latanoprost Eye Drops

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two eye conditions: ocular hypertension and primary open-angle glaucoma. These conditions are related to increased pressure in the eye, which can lead to vision problems if not managed properly. The study will use two types of eye drops containing the active ingredient latanoprost. One type of eye drop is called Xalatan, and the other is Monoprost, which is preservative-free. The purpose of the study is to compare the effects of these two treatments on the density of goblet cells, which are cells in the eye that help keep it moist and healthy.

Participants in the study will receive either the Xalatan or Monoprost eye drops. The study will observe changes in goblet cell density over a period of time. Additionally, the study will monitor changes in eye pressure and other factors related to eye health, such as the concentration of certain substances in the tear film and the condition of the eye's surface. The study will also assess any changes in symptoms related to dry eye.

The trial aims to provide valuable information on how these treatments affect eye health, particularly in terms of maintaining moisture and reducing pressure in the eye. This information could help improve treatment options for people with ocular hypertension and primary open-angle glaucoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, which is to compare the effects of two types of latanoprost eye drops on eye health.
You will be asked to provide consent to participate in the study, acknowledging that you understand the trial's procedures and objectives.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are at least 18 years old, have an intraocular pressure (IOP) of 22 mmHg or higher in each eye, and have been diagnosed with ocular hypertension or primary open-angle glaucoma.
Your ability to speak Danish will also be confirmed during this assessment.
Step 3
Medication administration
You will be randomly assigned to receive either BAK-preserved latanoprost eye drops or preservative-free latanoprost eye drops.
The eye drops will be administered as a solution, and you will be instructed to apply them as directed by the study team.
Step 4
Ongoing monitoring
Throughout the trial, your eye health will be monitored regularly. This includes measuring changes in goblet cell density, which are cells that help keep your eyes moist.
Other assessments will include changes in intraocular pressure, the health of your cornea and conjunctiva, and the concentration of certain substances in your tear film.
Step 5
Completion of trial
The trial is expected to continue until December 31, 2026. Upon completion, a final assessment will be conducted to evaluate the effects of the eye drops on your eye health.
The results will contribute to understanding the impact of different formulations of latanoprost on eye conditions.

Who can join the trial?

4 criteria

Must be at least 18 years old.
Must have an intraocular pressure (IOP) of at least 22 mmHg in each eye. This is a measure of the fluid pressure inside the eye, checked by an eye doctor.
Must have either ocular hypertension (OHT) or primary open angle glaucoma (POAG).
Must be able to speak Danish.

Who cannot join the trial?

3 criteria

Patients with any eye condition other than ocular hypertension or primary open angle glaucoma cannot participate. Ocular hypertension means higher pressure in the eye, and primary open angle glaucoma is a common eye condition where the optic nerve is damaged.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like children or those with certain disabilities.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Benzalkonium chloride
is a substance often used in eye drops as a preservative. In this trial, it is being used to see how it affects the number of goblet cells in the eye. Goblet cells are important because they help keep the eye moist and comfortable. The trial is looking at how this preservative might change the number of these cells when used in eye drops.
Latanoprost
is a type of eye drop used to treat high pressure inside the eye, which can help prevent vision problems. In this trial, there are two types of latanoprost eye drops being tested: one with a preservative called benzalkonium chloride and one without any preservatives. The trial aims to see how each type affects the number of goblet cells in the eye, which are important for keeping the eye healthy and comfortable.

Latanoprost

What is already known about the treatment

Latanoprost – Latanoprost is administered as eye drops and is used to treat conditions like ocular hypertension and primary open-angle glaucoma. It is a well-established medication in the field of ophthalmology, with extensive documentation in medical literature. The main therapeutic use of latanoprost is to reduce high pressure inside the eye, which can help prevent blindness. At the molecular level, it works by increasing the outflow of fluid from the eye, thereby lowering eye pressure. Latanoprost belongs to a class of drugs known as prostaglandin analogs.

Investigated diseases

Ocular hypertension
Ocular hypertension is a condition characterized by higher than normal pressure inside the eye, known as intraocular pressure. This increased pressure can occur when the eye produces too much fluid or when the fluid does not drain properly. Over time, the elevated pressure can cause damage to the optic nerve, although it does not always lead to vision loss. People with ocular hypertension often do not experience any symptoms, making regular eye exams important for detection. The condition can progress slowly, and monitoring is essential to prevent potential complications. It is distinct from glaucoma, as it does not always result in optic nerve damage or vision changes.
Primary open-angle glaucoma
Primary open-angle glaucoma is a chronic eye disease where the drainage angle formed by the cornea and iris remains open, but the trabecular meshwork becomes partially blocked. This blockage leads to a gradual increase in intraocular pressure, which can damage the optic nerve. The disease progresses slowly and often without noticeable symptoms until significant vision loss occurs. Peripheral vision is usually affected first, followed by central vision if the condition is not managed. Regular eye examinations are crucial for early detection and management. The progression can vary among individuals, and monitoring is important to prevent further damage.