Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction

This research is investigating a specific eye drop containing hydrocortisone (called Softacort) for adults who have dry eyes linked to Meibomian Gland Dysfunction (MGD). MGD is a common issue affecting the glands in your eyelids that make the oily part of your tears. The main goal is to see if this eye drop can reduce dry eye symptoms after 14 days. Researchers will also be checking for any changes in the amount of inflammation in the tears and looking very carefully for potential side effects, especially any increase in eye pressure. This is a "Phase 4" study, meaning the treatment has already been approved and this study is looking at how it performs in wider use. It aims to gather more information about its effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Laboratorios Thea S.A.

Enrolment target

Start

21 Oct 2024

Dry Eye and Meibomian Gland Dysfunction

What is this study about?

This research study is looking at a type of eye drop called Softacort, which contains a low dose of hydrocortisone. Hydrocortisone is a medicine that can help reduce inflammation, which is often a key part of conditions like dry eye.

The study involves people who have dry eye disease that's linked to something called Meibomian Gland Dysfunction (MGD). Your meibomian glands are tiny glands in your eyelids that produce an oily substance. This oil is super important because it helps stop your tears from evaporating too quickly. When these glands don't work properly, your eyes can become dry, irritated, and uncomfortable. The main aim of this study is to see if using these eye drops helps improve these dry eye symptoms after a couple of weeks, and to make sure they are safe for people to use.

Researchers will also be looking closely at other things, like how the drops affect the signs of dry eye that a doctor can see, such as redness or how quickly your tears dry up. They will also measure certain substances in your tears that are linked to inflammation. This helps them understand how the treatment is working on a deeper level. Because this is a "Phase 4" study, it means the medicine is already available, and this study helps us understand more about how it works for patients in everyday situations.

Key takeaways

This study is testing an eye drop for dry eyes linked to MGD.
It aims to see if the drop improves symptoms and is safe.
The study lasts about 12 weeks and involves several clinic visits.
It's open to adults aged 18 and above.
Doctors will carefully check for side effects, especially eye pressure changes.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. The study is open to both men and women.

More specific details about your eye health will be checked by the study doctors to make sure this research is right for you. They will need to confirm that you have dry eyes caused by Meibomian Gland Dysfunction of a moderate level.

Quick self-check

Are you 18 years old or older?
Do you have dry eye symptoms?
Has a doctor told you that your dry eyes are caused by Meibomian Gland Dysfunction?
Are you able to attend clinic visits over a 12-week period?

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 in this study, you will use the study eye drops (Softacort) as directed. You will have several visits to the study clinic over a period of about 12 weeks (84 days). During these visits, the doctors will carry out various examinations of your eyes. This will include checking your vision, looking at your eyelids and the surface of your eyes, and doing tests to measure how dry your eyes are and how quickly your tears evaporate. You will also be asked to complete questionnaires about your symptoms to help track how you are feeling.

Additionally, doctors will measure the pressure inside your eyes at different points during the study, as this is an important safety check for eye drops containing hydrocortisone. They may also collect a tiny sample of your tears to measure chemicals related to inflammation. The study will monitor any side effects you might experience. The total duration of your participation in the study from the first check-up to the final visit will be around 84 days.

Potential risks and benefits

Participating in this study might offer a potential benefit of improving your dry eye symptoms. It could also help advance medical understanding of how to better treat dry eye caused by MGD. However, like all medications, the eye drops might have side effects. The study will carefully monitor for any issues, particularly increased eye pressure, which can sometimes occur with steroid eye drops. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Spain

Common questions

What is Meibomian Gland Dysfunction (MGD)?

MGD is when the tiny glands in your eyelids that produce the oily layer of your tears don't work properly, leading to dry eyes.

What is hydrocortisone?

Hydrocortisone is a medicine that helps reduce swelling and inflammation.

Who can join this study?

Adults aged 18 and over, both men and women, with dry eyes caused by moderate MGD.

How long does the study last?

If you join, your participation will last for about 12 weeks (84 days).

Will I get paid for participating?

The information provided does not say if participants will be paid. You should ask the study team about this.