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

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What is this study about?

This clinical trial is focused on studying 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 evaluate the use of PRGF eye drops, which stands for Plasma Rich in Growth Factors, a treatment derived from blood components that may help in healing and reducing inflammation. The trial will compare the effectiveness and safety of these eye drops with artificial tear eye drops containing hypromellose, a substance that helps to lubricate the eyes.

The purpose of the study is to assess whether PRGF eye drops are more effective than artificial tears in treating Dry Eye Disease. Participants will be randomly assigned to receive either the PRGF eye drops or the artificial tear eye drops. The study will last for 12 weeks, during which participants will use the eye drops four times a day. Throughout the study, participants will have regular check-ups to monitor their eye health and any changes in their symptoms.

In addition to the main treatments, some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to provide valuable information on the safety and effectiveness of these treatments for Dry Eye Disease, potentially leading to better management options for those affected by this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, history of dry eye symptoms, and willingness to participate in all study visits and procedures.

2 initial assessment

An initial assessment is conducted to evaluate the severity of dry eye disease using tests like the OSDI questionnaire and the Oxford scale for ocular surface staining.

3 treatment phase part A

During Part A, the safety of PRGF eye drops is evaluated. These drops are administered four times daily for 12 weeks.

The focus is on monitoring any adverse events and assessing global tolerance at 2 and 12 weeks.

4 treatment phase part B

In Part B, the effectiveness of PRGF eye drops is compared to artificial tear eye drops containing 0.3% hypromellose.

The same administration schedule of four times daily for 12 weeks is followed.

5 mid-study evaluation

At 2 weeks, an evaluation is conducted to assess changes in symptoms using the OSDI questionnaire and the Oxford scale.

Additional assessments include changes in visual acuity, tear quantity, and intraocular pressure.

6 final evaluation

At 12 weeks, a final evaluation is performed to measure the evolution of symptoms and changes in ocular surface staining.

The study also assesses global tolerance and any adverse events reported during the trial.

Who Can Join the Study?

  • 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. This must be confirmed by a clinical diagnosis during the screening visit, with the following conditions met in at least one eye:
    • 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 way to measure damage to the surface of the eye.
  • OSDI test score of 23 or higher. This is a questionnaire that measures the severity of dry eye symptoms.
  • Patients must have signed an informed consent form, which means they agree to participate in the study after understanding what it involves.
  • Patients must be willing to attend all study visits and follow all procedures required by the study.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Dry Eye Disease cannot participate. Dry Eye Disease is a condition where your eyes do not produce enough tears or the right quality of tears to keep your eyes comfortable.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who might be at a higher risk of harm or exploitation.
  • Patients who are not able to use the study medication as required cannot participate. The study medication must be used four times daily for 12 weeks.
  • Patients who are not willing or able to follow the study procedures cannot participate. This includes attending all study visits and following instructions given by the study team.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Instituto Oftalmologico Fernandez-Vega S.L. Oviedo Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.10.2024

Trial locations

Investigated drugs:

PRGF eye drops are being tested in this clinical trial to see if they are safe and effective for people with dry eye disease. These eye drops are used four times a day for 12 weeks. The study aims to find out if these drops can help improve the symptoms of dry eye disease.

Artificial tear eye drops containing 0.3% hypromellose are also used in this trial. These drops are commonly used to relieve dryness and irritation in the eyes by providing extra moisture. The trial compares these drops to PRGF eye drops to see which is more effective for treating dry eye disease.

Investigated diseases:

Dry Eye Disease – Dry Eye Disease is a common 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 sensation, burning, or redness in the eyes. The condition can be exacerbated by environmental factors such as wind or air conditioning. Over time, it may cause inflammation and damage to the eye’s surface. People with this condition may experience fluctuating vision and increased sensitivity to light. It is often associated with other conditions like Sjögren’s syndrome or rosacea.

Trial ID:
2023-507357-15-00
Protocol code:
BTIIMD-02-EC-23-OJOS
Trial Phase:
Therapeutic confirmatory (Phase III)

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