AuthorisedTherapeutic use (Phase IV)Interventional

Randomized, parallel-group, double-blind clinical trial to evaluate the efficacy and safety of PRGF eye drops in patients with dry eye disease

This study is investigating new and existing treatments for dry eye disease. Researchers want to see how effective and safe different types of eye drops are when compared with each other. They are specifically testing eye drops made from your own blood, called 'Plasma Rich in Growth Factors' (PRGF), alongside two other common eye drop treatments (Artific 3 and Hidrathea). The main goal is to find out which eye drops best relieve dry eye symptoms and improve the surface of the eye, which is often affected by this condition. They will also be closely monitoring any side effects to make sure the treatments are safe for patients. This is an advanced-stage study, meaning these treatments have already been tested to some extent.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Biotechnology Institue I Mas D S.L.

Enrolment target

Start

26 May 2025

Dry Eye Disease

What is this study about?

Imagine your eyes feel gritty, sore, or watery, like there's something in them, even when there isn't. This is what it's like to have dry eye disease. It's a common condition where your eyes don't make enough tears, or the tears they do make aren't good quality. This can make everyday activities like reading or using a computer uncomfortable.

This study is looking into different ways to help people with dry eyes. The main focus is on a special type of eye drop called PRGF, which stands for 'Plasma Rich in Growth Factors.' This treatment is made from a small sample of your own blood, which is processed to get tiny parts that can help your eyes heal and feel better. This is being compared to two other commonly used eye drops to see which treatment works best for relieving symptoms and improving the eye's surface.

The researchers will be carefully checking how patients feel and how their eyes look over time. They want to know if these eye drops can reduce discomfort and help the eyes become healthier. This kind of study helps doctors understand the best ways to treat dry eye disease, offering hope for better relief for many people.

Key takeaways

The study explores new eye drop treatments for dry eyes.
It compares PRGF (from your own blood) with other standard drops.
It's a 12-week study looking at symptom relief and eye health.
Both effectiveness and safety are being carefully checked.
Participation could help improve future dry eye treatments.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. There isn't an upper age limit, so older adults are welcome to take part too.

Both men and women can participate in this research. The study needs a wide range of people to get the best possible information about the treatments.

You must have been diagnosed with dry eye disease to be considered for this study. The researchers will check your medical history to make sure you fit all the necessary criteria for the study.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of dry eye disease?
Are you able to attend clinic visits over a 12-week period?
Are you comfortable with using eye drops as prescribed?
Are you happy for your medical history to be reviewed for the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be given one of the three types of eye drops to use. You won't know which one you're getting, and neither will the study doctors – this helps make the results fair. You'll need to use the eye drops as instructed and attend a few clinic visits over a 12-week period.

At these visits, doctors will ask you about your symptoms using questionnaires and examine your eyes. They will also check your overall health and ask if you've experienced any side effects. There will be assessments at 2 weeks and 12 weeks to see how you're getting on. The total study duration for each participant is 12 weeks, with follow-up appointments.

Potential risks and benefits

Taking part in this study might help improve your dry eye symptoms, and you would be contributing to valuable research that could help others. However, there's no guarantee that any of the treatments will work for you. As with any medication, there's a chance of experiencing side effects, both in your eyes or elsewhere, although these will be carefully monitored. You are absolutely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is dry eye disease?

It's a common condition where your eyes don't produce enough tears, or the tears they make aren't good quality, leading to discomfort and irritation.

What are PRGF eye drops?

They are a special type of eye drop made from a small sample of your own blood. Your blood is processed to get 'Plasma Rich in Growth Factors,' which are natural healing substances.

Will I know which eye drops I'm using?

No, you won't know, and neither will the study doctors. This is called 'double-blind' and helps ensure the study results are fair and unbiased.

How long will I be in the study?

If you join, you will be part of the study for 12 weeks, attending appointments at 2 weeks and 12 weeks to check your progress.

What if I experience side effects?

Any side effects you experience will be carefully recorded and monitored by the study team. You should always report any new or worsening symptoms.