Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

This research study is investigating whether insulin eye drops can effectively treat dry eye disease and if they are safe to use. It's a type of study that looks at treatments already in use to understand them better. The main goal is to see if insulin helps heal the surface of the eye, which can get damaged with dry eyes, over a six-month period. Researchers will compare this to how well standard dry eye treatments work. They will also be checking other things like how much pain or discomfort people feel, how sensitive their eyes are, and how quickly their tears dry up. Safety is very important, so they will also be carefully monitoring for any unwanted side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital Clinico San Carlos

Enrolment target

120

Start

18 Oct 2024

Dry eye disease

What is this study about?

This study is looking into a condition called dry eye disease. If you have dry eyes, your eyes don't make enough tears, or the tears they do make aren't good quality. This can lead to your eyes feeling scratchy, burning, or watery, and your vision might even become blurry. It can be quite uncomfortable and affect your everyday life.

Researchers are particularly interested in a new idea: using insulin as an eye drop. Insulin is a hormone usually associated with blood sugar, but some early studies suggest it might also help heal and protect the surface of the eye. This study aims to find out if insulin eye drops are a good and safe way to treat dry eyes, especially when compared to treatments already available like artificial tears or other special eye drops.

The main thing the doctors will be checking is how much the surface of your eye improves. With dry eyes, the clear front part of your eye can get tiny damage spots. They will look at these spots at the start and then again after six months of treatment to see if they've gotten better. They will also be looking at other important aspects like how your symptoms change, how sensitive your eyes are, and how stable your tears are on your eye's surface.

Key takeaways

The study is investigating insulin eye drops for dry eye disease.
It aims to see if insulin improves the eye's healing process over 6 months.
Looks at safety and compares insulin to existing dry eye treatments.
Open to adults aged 18 and over.
Participation involves regular clinic visits and eye assessments for 6 months.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over, who have dry eye disease. Both men and women are welcome to take part.

Before you can join, the study doctors will need to check your medical history and do some tests to make sure the study is right for you and that you meet all the specific requirements. They want to make sure it's safe for you to take part and that the results of the study will be clear and helpful.

Even if you have dry eyes, there might be other health conditions or medications that would prevent you from joining, so it's important to discuss everything openly with the study team.

Quick self-check

Are you 18 years old or older?
Do you have dry eye disease?
Are you able to attend clinic visits regularly for six months?
Are you willing to potentially use different types of eye drops as part of 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 in this study, you will be given either insulin eye drops, artificial tears, or another type of dry eye treatment to use. You will visit the clinic regularly over a period of six months. At these visits, doctors will perform various eye checks, including examining the surface of your eye, asking you about your symptoms, checking how sensitive your eyes are, and measuring how long your tears stay on your eye. They will also keep a close eye on your general health and record any side effects you might experience. The total duration of your active participation, including all treatments and assessments, will be six months.

Potential risks and benefits

Taking part in this study could offer a potential benefit if the insulin eye drops prove to be more effective than current treatments for your dry eyes. However, there's no guarantee that you will personally benefit. As with any medication, there's a risk of side effects, which the study team will carefully monitor. You will be fully informed of any known risks before you agree to participate. Remember, your participation is completely voluntary, and you are free to withdraw from 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?

Dry eye disease happens when your eyes don't make enough tears or make poor-quality tears, leading to discomfort, burning, and sometimes blurred vision.

What are they testing in this study?

Researchers are testing if insulin eye drops are safe and effective in treating dry eyes, compared to standard dry eye treatments.

How long will the study last for me?

If you join, your active participation in the study, including treatment and check-ups, will last for six months.

Will I definitely get the insulin eye drops?

You might get insulin eye drops, artificial tears, or another indifferent preparation. The study is designed to compare these treatments.

What happens if I want to leave the study?

You are free to leave the study at any time without giving a reason, and it won't affect your future medical care.