AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin ophthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC)

This research study is looking into a new eye drop called T1695, designed to treat Vernal Keratoconjunctivitis (VKC). VKC is a serious eye allergy that can cause lasting damage. Researchers want to find out how effective and safe T1695 is compared to a treatment already in use, Ciclosporin eye drops. They will be observing how the new eye drops help improve signs of eye damage, like staining on the front of the eye. They'll also monitor symptoms such as itching, watering, and sensitivity to light. The study is currently in an early stage (Phase II) to gather more information about this potential new treatment for children and young people with moderate to severe VKC.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Laboratoires Thea

Enrolment target

Start

04 Nov 2025

Vernal Keratoconjunctivitis (VKC)

What is this study about?

This study is designed to explore a new potential treatment for Vernal Keratoconjunctivitis, often shortened to VKC. VKC is a long-term eye allergy that mainly affects children and young adults. It can be quite severe, causing significant discomfort and sometimes even damaging the surface of the eye, which is called the cornea.

The main goal of this research is to see how well a new eye drop, called T1695, works in treating VKC compared to another eye drop called Ciclosporin, which is already used for this condition. Specifically, the researchers will be looking at how T1695 helps to reduce changes to the cornea, which they measure using a special dye. They will also be tracking how much it improves everyday VKC symptoms like itchy eyes, watery eyes, feeling sensitive to light (photophobia), and mucus discharge.

This study is in an early stage of development, called Phase II. This means it's one of the first times this new treatment is being tested in a larger group of people. The information gathered will help doctors understand if T1695 is a promising treatment option for people with moderate to severe VKC.

Key takeaways

Tests new eye drops (T1695) for severe eye allergies (VKC).
Compares T1695 to an existing treatment (Ciclosporin).
Focuses on improving eye health and reducing symptoms like itching.
It's an early-stage study to check safety and effectiveness.
Open to people of all ages with moderate to severe VKC.

Who may be eligible?

This study is looking for people with moderate to severe Vernal Keratoconjunctivitis (VKC).

It is open to a wide range of ages, both males and females. The study team will check if your VKC is moderate to severe and if you meet all the other health requirements to take part safely.

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.

Do I have moderate to severe Vernal Keratoconjunctivitis (VKC)?
Am I willing to use eye drops regularly as instructed?
Can I attend regular clinic visits for eye checks and health assessments?
Am I comfortable completing questionnaires about my symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new eye drops (T1695) or the existing treatment (Ciclosporin). You would need to use these eye drops regularly as instructed by the study team. You would also have several visits to the clinic over a period of time. During these visits, doctors and nurses would perform various checks on your eyes, such as looking at your cornea, checking for specific signs of VKC, and asking you about your symptoms using questionnaires. They will also assess your general health and how the treatment is affecting you. These visits are important for tracking how well the treatment is working and making sure it's safe for you. The total duration of your participation would involve regular checks up to about 4 weeks, with further follow-up visits to monitor your eyes and general well-being.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new treatment that might help your condition, which could be a potential benefit. However, there are also potential risks, as with any medication. The new eye drops might have side effects, or they might not work as well as expected. The study team will carefully monitor you for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
Bulgaria
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Unverified
France
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Unverified
Greece

Common questions

What is Vernal Keratoconjunctivitis (VKC)?

VKC is a long-term, severe form of eye allergy that mainly affects children and young adults, causing itchy, watery, and painful eyes, and can sometimes damage the front of the eye.

What is being tested in this study?

This study is testing a new eye drop called T1695, comparing it to an already used treatment called Ciclosporin eye drops, to see how well it treats VKC.

How will the doctors know if the treatment is working?

Doctors will check the surface of your eye for any changes and ask you about your symptoms like itching, watering, and sensitivity to light.

What is a 'Phase II' clinical trial?

This is an early stage of testing for a new medicine, where researchers look at how safe it is and how well it works in a small group of people.

Will I definitely receive the new eye drops?

You will either receive the new eye drops (T1695) or the existing treatment (Ciclosporin). The study is designed to compare the two.