Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared with Vehicle in Subjects with Fuchs Endothelial Corneal Dystrophy (FECD) - PHANTOM Study

The PHANTOM study is testing a new eye drop, STN1010904, for people with Fuchs Endothelial Corneal Dystrophy (FECD), a condition affecting the front of the eye. This study aims to find out if these eye drops can help improve vision, including how well people see in different light conditions, and if they are safe to use. Some participants will receive the active eye drops, while others will receive a placebo – a dummy drop that looks the same but contains no medicine. This helps researchers compare the effects accurately. The study will look closely at changes in eyesight over 18 months, as well as checking for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Santen Inc.

Enrolment target

Start

04 Oct 2024

Fuchs Endothelial Corneal Dystrophy (FECD)

What is this study about?

This research study, known as the PHANTOM study, is investigating a new eye drop treatment called STN1010904 for a specific eye condition called Fuchs Endothelial Corneal Dystrophy (FECD). FECD is a condition where cells on the inner surface of the cornea (the clear front part of the eye) gradually stop working properly. This can lead to the cornea swelling and becoming cloudy, which often causes blurred vision, glare, and difficulty seeing in certain lighting conditions.

The main goal of this study is to see if the STN1010904 eye drops can help improve the vision of people with FECD and to check if they are safe to use. Researchers will be looking at how well people can see, including their ability to read eye charts and their sensitivity to contrast (how well they can tell the difference between light and dark shades), especially in bright or glaring light. They are hoping to find out if these drops can slow down or even reverse some of the vision problems caused by FECD.

To ensure the results are fair and accurate, some participants will receive the active STN1010904 eye drops, while others will receive a placebo – a drop that looks identical but contains no active medicine. Neither the participants nor their doctors will know who is getting which treatment. This is a common way to test new medicines and helps researchers understand if any improvements are due to the treatment itself or other factors. The study will carefully monitor participants' vision and general eye health over an 18-month period.

Key takeaways

The PHANTOM study is testing new eye drops for Fuchs Endothelial Corneal Dystrophy (FECD).
It aims to see if the drops can improve vision and are safe.
Participants will receive either the new drops or dummy drops (placebo).
The study lasts 18 months and involves regular eye checks.
It's important to understand this is a research study and not a guaranteed treatment.

Who may be eligible?

To join this study, people must be at least 18 years old. The study is open to both men and women.

More detailed checks will be done by the study team to make sure it's safe and appropriate for someone to take part. For example, they will need to confirm the diagnosis of Fuchs Endothelial Corneal Dystrophy and check other aspects of your health and eye condition.

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?
Have you been diagnosed with Fuchs Endothelial Corneal Dystrophy?
Are you able to attend regular study appointments for 18 months?
Are you comfortable with the possibility of receiving a placebo (dummy drops)?
Are you generally in good health other than your eye condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given eye drops to use regularly. These could be the new active treatment (STN1010904) or a placebo (dummy drops). You will be regularly seen by the study team over an 18-month period. These visits will involve various eye tests to check your vision, including how well you read eye charts and how you see in different light conditions. They will also include checks for any changes in your eye health, such as using special lights to look at your eye, measuring the pressure inside your eye, and potentially taking blood and urine samples. The study team will guide you through all the assessments and explain how often you will need to attend.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as contributing to medical knowledge and potentially receiving a new treatment that might improve your vision. However, there's no guarantee of personal benefit, and the eye drops may not work for everyone. As with any medication, there's a risk of side effects, which will be carefully monitored throughout the study. You will be told about all known risks before you decide to join. It is very important to remember that 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
France

Common questions

What is Fuchs Endothelial Corneal Dystrophy (FECD)?

It's an eye condition where special cells at the front of your eye don't work well, causing your cornea to swell and vision to become blurry.

What are 'placebo' eye drops?

Placebo drops look exactly like the active treatment but don't contain any medicine. They help researchers compare the real effects of the drug.

Will I know if I'm getting the active eye drops or the placebo?

No, neither you nor your study doctor will know which drops you are receiving. This is to ensure fair and unbiased results.

How long will I need to be involved in the study?

The main part of the study involves treatments and check-ups over an 18-month period.

What kind of tests will I have?

You'll have vision tests, eye examinations with special lights, eye pressure checks, and possibly blood and urine tests.