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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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What is this trial about?

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

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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

2 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Endoret® (PRGF-Plasma Rich in Growth Factors) – This medication is administered topically to the eye, specifically designed for patients with glaucoma who are undergoing chronic treatment with ocular hypotensive drugs. Currently, it is being evaluated in clinical trials for its regenerative effects on the ocular surface. The main therapeutic indication is to improve the health of the eye surface in glaucoma patients. At the molecular level, it works by utilizing growth factors to promote tissue repair and regeneration. It is classified pharmacologically as a regenerative therapy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520642-29-00Estimated enrolment30 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).