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Study on the Effectiveness of PRGF Eye Drops for Treating Dry Eye in Glaucoma Patients

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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 two eye conditions: glaucoma and dry eye disease. The treatment being tested is called Plasma rich in growth factors, which is used in the form of eye drops. These eye drops contain a special substance known as platelet concentrate, which is derived from blood and is believed to help with healing and reducing symptoms of dry eyes.

The purpose of the study is to evaluate how effective these eye drops are in relieving symptoms of dry eye disease in patients who also have glaucoma. Participants in the study will be randomly assigned to receive either the Plasma rich in growth factors eye drops or a different preservative-free eye drop formulation. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results.

Throughout the study, participants will use the eye drops for a period of up to 12 months. During this time, they will have regular check-ups to monitor changes in their eye condition, such as the degree of eye dryness and any improvements in symptoms. The study will also assess the safety of the treatment by keeping track of any side effects experienced by the participants. The goal is to determine if the Plasma rich in growth factors eye drops can provide a safe and effective treatment option for people suffering from dry eye disease alongside glaucoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have already provided signed and dated informed consent. This confirms understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes checking for controlled glaucoma or ocular hypertension, and a diagnosis of moderate to severe dry eye syndrome.

    The patient must have stopped using artificial tears at least one week before this assessment.

  3. Step 3

    Treatment phase

    The patient will begin using the PRGF eye drops as part of the treatment for dry eye disease. These are administered for ophthalmic use.

    The dosage, frequency, and duration of administration will be provided by the study team and must be followed as instructed.

  4. Step 4

    Follow-up assessments

    The patient will have follow-up assessments at 3 months and 6 months. These assessments will evaluate changes in eye condition using various tests such as the Oxford scale for ocular staining, the Ocular Surface Disease Index (OSDI) for symptomatology, and the Schirmer test for tear production.

    Additional evaluations will include tear breakup time (TBUT), conjunctival hyperemia, and visual acuity.

  5. Step 5

    Safety and tolerance evaluation

    Throughout the trial, the safety and tolerance of the treatment will be assessed. This includes monitoring for any ocular or systemic adverse events.

    Both the investigator and the patient will assess global tolerance at 3 and 6 months.

  6. Step 6

    End of trial

    The trial is estimated to end by September 1, 2025. At this point, the final assessments will be conducted, and the patient will receive information about the results and any further steps if necessary.

Who can join the trial?

11 criteria

  • Signed and dated informed consent.
  • Man or woman over 50 years of age.
  • Have controlled glaucoma or ocular hypertension (OHT) that requires medication with at least one active ingredient containing preservatives and have symptoms of dry eyes.
  • Must have stopped using artificial tears at least one week before the study visit.
  • Have a diagnosis of moderate to severe dry eye syndrome, which is determined by an OSDI score of 13 or higher. The OSDI is a questionnaire that measures the severity of dry eye symptoms.
  • Have at least one eye that meets the following conditions:
    • Total eye staining (cornea and conjunctiva) with an Oxford scale grade between 2 to 5. The Oxford scale is a way to measure eye surface damage.
    • At least one of these objective signs:
      • Schirmer's test result between 3 mm/5 min and 9 mm/5 min. Schirmer's test measures tear production.
      • TBUT (Tear Break-Up Time) of less than 10 seconds. TBUT measures how quickly tears evaporate from the eye surface.
      • For patients with glaucoma: Must have optic nerve involvement compatible with glaucoma, shown by previous optical coherence tomography (OCT), regardless of visual field defects or intraocular pressure (IOP) levels. OCT is an imaging test that shows detailed images of the eye.
      • For patients with OHT: Must have an IOP greater than 21 mmHg in at least two measurements, without optic nerve involvement, and require treatment to lower eye pressure.
      • No progression of OHT or glaucoma in the year before the study, as shown by OCT and/or visual field tests.

Who cannot join the trial?

3 criteria

  • Patients who do not have glaucoma or dry eye disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who belong to a vulnerable population cannot participate.
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Investigated drugs

PRGF eye drops are a type of eye drop used in this clinical trial to help treat dry eye disease in patients who also have glaucoma. PRGF stands for Plasma Rich in Growth Factors, which means these eye drops are made from components found in blood that can help promote healing and reduce inflammation. The goal of using PRGF eye drops in this trial is to see if they can effectively relieve the symptoms of dry eyes, such as irritation and discomfort, in people who have glaucoma.

What is already known about the treatment

PRGF eye drops – PRGF eye drops are administered directly into the eyes and are being studied for their potential benefits in treating dry eye disease, particularly in patients who also have glaucoma. Currently, these eye drops are under investigation in clinical trials, and their effectiveness and safety are being evaluated. The main therapeutic use being explored is the relief of symptoms associated with dry eye disease. At the molecular level, PRGF eye drops are believed to work by promoting healing and reducing inflammation in the eye, although the exact mechanism is still being studied. They are classified pharmacologically as a treatment for eye conditions, specifically targeting dry eye symptoms.

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 erode the optic nerve tissue, leading to vision loss or even blindness. The progression of glaucoma is typically slow and may not be noticeable until significant damage has occurred. It can affect one or both eyes and is more common in older adults. Regular eye exams are important to detect changes in eye pressure and optic nerve health.

  • Dry Eye Disease

    Dry eye disease occurs when the eyes do not produce enough tears or when the tears evaporate too quickly. This condition leads to inflammation and damage to the eye's surface. Symptoms include a stinging or burning sensation, redness, and a feeling of having something in the eye. The disease can progress to cause blurred vision and eye fatigue. It is often chronic and can affect daily activities such as reading or using a computer. Environmental factors, prolonged screen time, and certain medical conditions can exacerbate the symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519460-40-00Estimated enrolment70 patientsSponsorBiotechnology Institute I Mas D S.L.

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).