AuthorisedTherapeutic exploratory (Phase II)Interventional

Evaluation of the regenerative efficacy of Endoret® (PRGF-Plasm Rich in Growth Factors) on the ocular surface of glaucoma patients treated chronically with ocular hypotensive drugs, Evaluación de la eficacia regenerativa de Endoret® (PRGF-Plasma Rico en Factores de Crecimiento) en la superficie ocular de pacientes glaucomatosos tratados de forma crónica con fármacos hipotensores oculares

This research is looking into a new treatment called Endoret® for people living with glaucoma. Glaucoma often requires long-term use of eye drops, which can sometimes lead to uncomfortable dry eye. This study wants to find out if Endoret® can help make the surface of the eye healthier and more comfortable for these patients. We'll be focusing on a key measurement called 'tear osmolarity,' which is a way to check for dryness in the eye. High tear osmolarity can be a sign of problems with the eye's surface. By seeing if Endoret® can improve this measurement, we hope to understand if it could be a helpful new option for managing eye surface issues related to glaucoma treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Enrolment target

Start

29 Jan 2025

glaucoma

What is this study about?

This study is investigating a treatment called Endoret® for people who have glaucoma. Glaucoma is a condition that affects your eyesight, and many people with it need to use eye drops regularly to keep their eye pressure under control. While these drops are very important, long-term use can sometimes lead to other problems, like a dry or uncomfortable feeling on the surface of the eye. This discomfort is often due to changes in the quality of your tears.

The main goal of this research is to see if Endoret® can help restore the health of the eye's surface and improve tear quality. Researchers believe that Endoret®, which comes from your own blood and contains special 'growth factors,' might encourage healing and regeneration in the eye. By making the eye surface healthier, the hope is that patients will experience less dryness and more comfort.

To check if Endoret® is working, the study will measure something called 'tear osmolarity.' This is a scientific way of looking at how watery or concentrated your tears are. If your tears are too concentrated, it's a sign of dry eye. Researchers will take a small, quick tear sample to see if Endoret® helps to make your tears more balanced and less concentrated, which would mean an improvement in the health of your eye surface.

Key takeaways

This study is testing Endoret® for eye surface problems in glaucoma patients.
It aims to make eyes more comfortable for those using long-term glaucoma eye drops.
We will measure 'tear osmolarity' to check for improvements in eye dryness.
The treatment uses beneficial substances from your own blood.
Participation involves clinic visits and tear samples, not surgery.

Who may be eligible?

This study is looking for volunteers who have glaucoma. You must be at least 18 years old to take part, and there is no upper age limit, so older adults are welcome to participate. Both men and women are encouraged to consider joining the study.

To be considered, you should also be someone who has been using eye drops frequently to manage your glaucoma for a longer period. This is because the study is specifically looking at how the new treatment might help with eye surface issues that can arise from long-term eye drop use.

There might be other specific health requirements or conditions that would prevent you from joining, which the study team will discuss with you. It's always best to talk to your eye doctor or the study team directly to see if this study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have glaucoma?
Do you use eye drops regularly for your glaucoma?
Are you able to attend clinic visits as required?
Are you interested in a new treatment for eye surface comfort?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the Endoret® treatment. The exact details of how and when this is given would be fully explained by the study team. You would also have several visits to the clinic so that researchers can monitor your eye health and how you are responding to the treatment.

During these visits, the main thing they will check is your 'tear osmolarity.' This involves taking a tiny, painless sample of your tears using a special device. It's very quick and gives immediate results, helping the doctors understand any changes in your eye's dryness. They will compare these measurements from before you started the treatment to later on. There might also be other standard eye checks performed, similar to what you might have at a regular eye appointment. The total length of your involvement in the study would be discussed with you upfront.

Potential risks and benefits

Participating in this study might offer a potential benefit of improving the comfort and health of your eye's surface, especially if you experience dryness due to your glaucoma eye drops. There is also the benefit of contributing to medical knowledge that could help future glaucoma patients. As with any medical treatment, there could be potential risks or side effects, which the study team will explain in detail. These could include irritation, discomfort, or other reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is glaucoma?

Glaucoma is an eye condition where the optic nerve, which connects your eye to your brain, becomes damaged, often due to high pressure inside your eye. It can lead to vision loss if not treated.

What is Endoret®?

Endoret® is a treatment made from your own blood, which is specially prepared to contain beneficial 'growth factors.' These growth factors are substances that help in healing and regeneration.

What does 'tear osmolarity' mean?

Tear osmolarity is a way to measure how concentrated or watery your tears are. A high reading can be a sign of dry eye syndrome.

Will taking part involve surgery?

This study is focused on a treatment that helps the surface of the eye. It does not involve surgery, but the exact way Endoret® is given will be fully explained to you.

Will I have to stop my current glaucoma eye drops?

It's highly unlikely you would need to stop your regular glaucoma treatment. This study aims to see if Endoret® can help with side effects of existing treatments. The study team will advise you on all your medications.