Study on the Effects of Fibrin Matrix on Eye Health in Glaucoma Patients Using Long-Term Eye Pressure Medications

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What is this study about?

This clinical trial is focused on studying glaucoma, a condition that affects the eyes and can lead to vision loss if not managed properly. The study will explore the effects of a treatment called ENDORET-PRGF, which is a solution for injection containing a substance known as fibrin matrix. This treatment is designed to help regenerate the surface of the eye in patients who have been using medications to lower eye pressure for a long time.

The purpose of the study is to evaluate how this treatment affects the eye’s surface, particularly by looking at changes in the saltiness of tears, known as tear osmolarity. This is important because an increase in tear osmolarity can indicate problems with the eye’s surface. The study will involve patients who have been using at least two different eye pressure-lowering medications for at least two years. Participants will receive the treatment and have their tear osmolarity measured using a simple, painless method that provides immediate results.

The study will take place over a period of time, during which participants will receive the treatment and have their tear osmolarity checked at different points. The goal is to see if the treatment can help improve the condition of the eye’s surface in patients with glaucoma who have been on long-term medication. This research could provide valuable insights into new ways to support eye health in individuals with this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This involves verifying the diagnosis of glaucoma and ensuring the patient has been using at least two ocular hypotensive drugs without preservatives for a minimum of two years.

2 baseline measurement

A baseline measurement of tear osmolarity is taken using the Tearlab® system. This involves a painless collection of a 30-nanoliter tear sample with immediate results. This measurement is referred to as V0.

3 treatment phase

The patient receives a solution for injection called ENDORET-PRGF, which contains a fibrin matrix. This treatment is applied topically to the ocular surface. The frequency and duration of administration are determined by the study protocol.

4 follow-up measurement

After the treatment phase, a follow-up measurement of tear osmolarity is conducted. This is referred to as V2. The difference in tear osmolarity between V0 and V2 is evaluated to assess the treatment’s effectiveness.

5 completion of trial

The trial is estimated to end on January 22, 2026. At this point, all data collected will be analyzed to determine the regenerative efficacy of the treatment on the ocular surface.

Who Can Join the Study?

Must be an adult diagnosed with glaucoma. Glaucoma is a condition that affects the eyes and can lead to vision loss if not treated.
Currently receiving treatment with at least two eye pressure-lowering medications. These medications should be used as eye drops, at least three times a day.
The eye drops used must not contain preservatives. Preservatives are chemicals added to products to prevent the growth of bacteria and other harmful organisms.
Must have been on this treatment for at least the last two years.
Must agree to participate in the study by giving consent.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with glaucoma cannot participate. Glaucoma is a condition that affects the eyes and can lead to vision loss.
Patients who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hijbhuog De Lc Sqzbb Cspg I Sfpq Pky	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	22.01.2025

Trial locations

Endoret® (PRGF-Plasma Rich in Growth Factors) is a treatment used in this trial to evaluate its regenerative effects on the eye surface. It is derived from the patient’s own blood and is rich in growth factors, which are proteins that help in healing and tissue regeneration. This therapy is applied topically to the eyes of patients with glaucoma who have been using eye pressure-lowering medications for a long time. The main goal is to see how this treatment affects the balance of salt and water in the tears, which is important for eye health.

Investigated diseases:

Glaucoma

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is crucial for good vision. This damage is often caused by abnormally high pressure in the eye. Over time, increased pressure can lead to the gradual loss of peripheral vision. If left unchecked, it can progress to tunnel vision and eventually lead to blindness. The condition can develop slowly, often without noticeable symptoms until significant damage has occurred. Regular eye exams are important to detect changes in eye pressure and optic nerve health.

Trial ID:

2025-520642-29-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Fibrin Matrix on Eye Health in Glaucoma Patients Using Long-Term Eye Pressure Medications

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