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Study on the Use of PRGF Eye Drops for Treating Dry Eye Disease in Patients

Registered drugNo placebo
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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 the effects of a new treatment for Dry Eye Disease, a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort and vision problems. The study will test the effectiveness and safety of eye drops made from Plasma Rich in Growth Factors (PRGF), which are derived from blood and contain substances that may help heal and protect the eye surface. These eye drops will be compared to standard artificial tear eye drops containing hypromellose, a common ingredient used to relieve dry eyes.

The purpose of the study is to evaluate how well the PRGF eye drops work and how safe they are for people with dry eye disease. Participants will use the eye drops four times a day for 12 weeks. During this time, they will have regular check-ups to monitor their eye health and any changes in their symptoms. The study will also include a comparison with a placebo to better understand the effects of the PRGF eye drops.

Throughout the study, participants will be asked to complete questionnaires about their symptoms and any side effects they experience. The study aims to provide valuable information on whether PRGF eye drops can offer a better treatment option for those suffering from dry eye disease compared to existing artificial tear solutions. The trial is expected to continue until 2027, with recruitment starting in 2025.

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

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and a history of dry eye symptoms.

    A series of tests are conducted to assess the condition of the eyes, including the tear film break-up time and ocular surface staining.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups. One group receives PRGF eye drops, and the other receives artificial tear eye drops containing 0.3% hypromellose.

    This process ensures that the study results are unbiased and reliable.

  3. Step 3

    Treatment phase

    Participants administer the assigned eye drops four times daily for a duration of 12 weeks.

    The eye drops are used to evaluate their effectiveness and safety in treating dry eye disease.

  4. Step 4

    Follow-up visits

    Follow-up visits are scheduled at 2 weeks and 12 weeks to monitor progress and assess any changes in symptoms.

    During these visits, participants complete the OSDI questionnaire to report on symptom changes and undergo further eye examinations.

  5. Step 5

    Safety and efficacy assessment

    The safety of the eye drops is evaluated by monitoring any adverse events, both related to the eyes and overall health.

    The effectiveness is assessed by changes in symptoms, tear production, and other eye health indicators.

  6. Step 6

    Final evaluation

    At the end of the 12-week period, a final evaluation is conducted to determine the overall impact of the treatment.

    Participants provide feedback on their experience and any changes in their condition.

Who can join the trial?

6 criteria

  • Patients must be at least 18 years old.
  • Patients should have a history of self-reported symptoms of Dry Eye Disease for at least 3 months, confirmed by a clinical diagnosis during the screening visit. This includes:
    • Tear film break-up time of 10 seconds or less. This is a test to see how quickly tears evaporate from the eye.
    • Ocular surface staining greater than 1 on the Oxford scale. This is a test to check for damage on the surface of the eye.
    • Patients must have an OSDI test score of 23 or higher. The OSDI test measures the severity of dry eye symptoms.
    • Patients must have signed an informed consent form, which means they understand the study and agree to participate.
    • Patients must be willing to attend all study visits and complete all study procedures.

Who cannot join the trial?

9 criteria

  • Patients who are not diagnosed with Dry Eye Disease cannot participate.
  • Patients who are under 18 years old or over 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who are not willing to use the study eye drops four times daily for 12 weeks cannot participate.
  • Patients who are currently using other treatments for dry eye disease that cannot be stopped during the study cannot participate.
  • Patients with any other eye conditions that might interfere with the study cannot participate.
  • Patients who have had eye surgery in the last 6 months cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a known allergy to any component of the study eye drops cannot participate.
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Investigated drugs

  • PRGF eye drops

    are a type of eye drop made from a special part of your own blood. They are designed to help heal and soothe the surface of your eyes. In this trial, they are being tested to see if they can help people with dry eye disease feel better and improve their eye health. The drops are used four times a day for 12 weeks to see how safe and effective they are.

  • Artificial tear eye drops

    are a common treatment for dry eyes. They work by adding moisture to the eyes, which can help relieve the discomfort and irritation caused by dryness. In this trial, artificial tear eye drops containing 0.3% hypromellose are used as a comparison to see if the PRGF eye drops are more effective in treating dry eye disease.

What is already known about the treatment

PRGF eye drops – PRGF eye drops are administered directly into the eyes, typically four times a day, to help manage dry eye disease. Currently, these eye drops are being studied in clinical trials to assess their safety and effectiveness compared to standard artificial tear eye drops. The main therapeutic use of PRGF eye drops is to relieve symptoms of dry eye disease, which can include irritation, redness, and a gritty feeling in the eyes. At the molecular level, PRGF eye drops are believed to work by promoting healing and reducing inflammation in the eye's surface, although the exact mechanism is still under investigation. They are classified as a treatment for eye conditions, specifically targeting dry eye symptoms.

Investigated diseases

Dry Eye Disease – Dry Eye Disease is a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to dryness and irritation. It often results in a gritty or burning sensation in the eyes, redness, and blurred vision. The disease progresses as the tear film becomes unstable, causing inflammation and damage to the eye's surface. Over time, this can lead to increased discomfort and potential complications with vision. Environmental factors, prolonged screen time, and certain medical conditions can exacerbate the symptoms. The condition can vary in severity, with some individuals experiencing mild discomfort and others facing more persistent and bothersome symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507357-15-01Protocol codeBTIIMD-02-EC-23-OJOSEstimated enrolment54 patientsSponsorBiotechnology Institute I Mas D S.L.

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