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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hyzorldj Urgcwmoohplzo Dmphjetr	Donostia / San Sebastian	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	08.11.2022

Trial locations

Investigated drugs:

Platelet Concentrate

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.

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 ID:

2024-519460-40-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

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