A Study Comparing Tacrolimus and Ciclosporin Eye Drops for Children and Adults with Moderate to Severe Vernal Keratoconjunctivitis

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What is this study about?

This study is looking at Vernal Keratoconjunctivitis, a condition that affects the eyes and causes symptoms like sensitivity to light, excessive tearing, itching, and mucus discharge. The study will compare two different eye drop treatments to see which one works better for people with moderate to severe forms of this condition. One treatment is T1695, which contains tacrolimus monohydrate and is given as an eye drop suspension twice a day. The other treatment is Verkazia, which contains ciclosporin and is given as an eye drop emulsion four times a day. The purpose of the study is to compare how well these two treatments work in reducing damage to the surface of the eye, specifically the clear front part of the eye called the cornea.

The study will involve children and teenagers between 4 and 18 years old who have moderate to severe symptoms and have experienced flare-ups of the condition in the past year. Participants will receive one of the two eye drop treatments for about six months. During this time, doctors will check how the eyes are responding to treatment by looking at changes in corneal damage, symptoms like itching and tearing, and overall eye health. The study will measure these changes at different time points, starting from the beginning of treatment through the end of the study period. Doctors will use special scales and measurements to track improvements in eye surface damage and will ask participants about their symptoms and quality of life.

Throughout the study, safety will be monitored by checking for any unwanted effects from the eye drops, measuring blood pressure and other vital signs, and doing blood tests to check kidney and liver function. For participants receiving T1695, blood samples will be taken to measure the amount of tacrolimus in the bloodstream. The study will also track whether participants need additional rescue medications and whether the condition comes back after treatment is stopped. The entire study will last several months and will help determine which treatment is more effective and safer for managing this eye condition in young people.

1 Treatment preparation and baseline assessment

Before starting treatment, your current medications for vernal keratoconjunctivitis (a seasonal eye condition causing inflammation) will need to be stopped for a specified period. This is called a washout period.

At the first visit (Day 1), several baseline measurements will be taken. These include assessment of corneal fluorescein staining (a test using a special dye to check for damage to the surface of your eye) using a scale from 0 to 5 in both eyes.

You will be asked to rate four eye symptoms on a scale from 0 to 100: sensitivity to light, tearing, itching, and mucous discharge.

A quality of life questionnaire will be completed to assess how the condition affects daily activities and school attendance.

Additional eye examinations will be performed using a slit lamp (a microscope for examining the eye), including checks for redness, specific signs of the condition, and examination of the inner surface of your eyelids.

Your visual acuity (sharpness of vision) will be measured in both eyes.

Intraocular pressure (pressure inside the eye) will be measured in both eyes.

Vital signs such as blood pressure and heart rate will be recorded.

A blood sample will be taken before the first dose to measure baseline levels and to check blood count, kidney function, and liver function.

Another blood sample will be taken between 1 and 3 hours after the first dose to measure the concentration of the study medication in your blood.

2 Treatment period with study medication

You will be assigned to receive one of two treatments for your eyes.

If assigned to T1695 (tacrolimus 0.1%): you will apply one drop in each eye twice daily for 3 months (85 days).

If assigned to ciclosporin 0.1%: you will apply one drop in each eye four times daily for 3 months (85 days).

This 3-month treatment period is called Period 1 and should occur during the season when your symptoms are typically present.

3 Follow-up visit at Day 29

At Day 29 (Week 4), you will return for an assessment visit.

The same eye examinations performed at baseline will be repeated, including the corneal fluorescein staining test in both eyes.

You will again rate your four eye symptoms on the 0 to 100 scale.

The examining doctor will assess various signs of your condition using the slit lamp, including severity of the condition, redness, and specific features on the eye surface.

The presence of any corneal ulcer (an open sore on the clear front surface of the eye) will be checked.

The doctor will evaluate how well the treatment is working.

You will be asked about the tolerability of the eye drops.

A blood sample will be taken between 1 and 3 hours after your dose to measure the medication concentration in your blood.

4 Additional follow-up visits during treatment

You will have additional visits at other time points during the 3-month treatment period.

At each visit, eye examinations will be repeated to monitor changes in your condition.

The corneal fluorescein staining test will be performed in both eyes.

You will rate your symptoms using the same scales.

The quality of life questionnaire will be completed again to assess any changes.

The doctor will check for corneal ulcers and assess whether you are responding to treatment.

Any use of additional rescue medications will be recorded.

Intraocular pressure will be measured in both eyes.

Vital signs will be recorded.

You will be asked about the tolerability of the eye drops.

5 End of treatment assessment

At Day 85, which marks the end of the 3-month treatment period, a comprehensive assessment will be performed.

All eye examinations will be repeated, including corneal fluorescein staining, symptom ratings, and slit lamp examinations in both eyes.

The quality of life questionnaire will be completed.

Visual acuity will be measured in both eyes.

Intraocular pressure will be measured in both eyes.

Vital signs will be recorded.

A blood sample will be taken to check blood count, kidney function, and liver function.

The doctor will assess the overall effectiveness of the treatment and the tolerability of the eye drops.

6 Follow-up period after treatment

After completing the 3-month treatment period, you will enter a follow-up phase.

You will continue to have visits where the same eye examinations are performed.

At each visit, changes from both the initial baseline (Day 1) and from the end of treatment (Day 85) will be assessed.

The doctor will monitor for any return of active symptoms, which is called recurrence.

If recurrence occurs, the time from the end of treatment to when symptoms return will be recorded.

All eye measurements, symptom ratings, and examinations will continue to be performed at each follow-up visit.

Intraocular pressure will be measured in both eyes.

Vital signs will be recorded.

The tolerability and any side effects will continue to be monitored throughout this period.

7 Safety monitoring throughout the study

Throughout the entire study, any side effects or adverse events will be carefully recorded.

Both eye-related and general body-related side effects will be monitored.

Any serious adverse events will be documented.

If side effects lead to stopping the study treatment, this will be recorded.

The safety of the eye drops will be assessed by both the examining doctor and by you (or your parent or guardian) at each visit.

Who Can Join the Study?

Requirements to participate in this study:

You must be between 4 years and less than 18 years old
You must have Vernal Keratoconjunctivitis (a type of eye inflammation caused by allergies) that affects both eyes
Your condition must be moderate to severe, which means it causes significant problems with your eyes
You must have had at least one flare-up (return of symptoms) of your eye condition in the past year
Your condition must be one of the following: not responding well to anti-allergy medicines, requiring steroid medicines regularly, or not improving enough with ciclosporin eye drops (a medicine that calms down the immune system)
You must need treatment for your eye condition and have no reasons why you cannot use ciclosporin or tacrolimus (medicines that help control inflammation)
You must be able to safely stop your current eye medicines for a period of time before starting the study, or switch to a different medicine with a shorter waiting period
You must be able to join the study during the season when your symptoms are active, so the 3-month treatment period happens during this time
At the time of joining, your eyes must show severe damage to the cornea (the clear front part of the eye) based on a special staining test
At the time of joining, you must have significant symptoms such as sensitivity to light, tearing, itching, or mucus discharge that you rate as quite severe
At the time of joining, your quality of life must be affected by your eye condition based on a questionnaire score
You (and your parent or legal guardian) must sign and date a consent form agreeing to participate before any study procedures begin

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate
If you have questions about whether you can join this study, you will need to discuss your individual situation with the study doctors during the screening process, which is the time when doctors check if you are suitable for the study
General factors that might affect participation will be reviewed by the medical team based on your health condition and medical history

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Fundacion De Oftalmologia Medica De La Comunitat Valenciana	Valencia	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Multimedica S.p.A.	Milan	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD	Varna	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Universita’ Di Pisa	Pisa	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Hopital Beaujon	Clichy	France
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD	Sofia	Bulgaria
Llqie Gesolyn Haoxmrsj Od Agozri	Athens	Greece
Fcacbznzi Puwn Lg Iwaestjcwgucn Btenexuuh Dlb Hdslwmrr Unevxxauhaeis Lx Pgj	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	01.03.2026
France	Not yet recruiting	01.03.2026
Greece	Not yet recruiting	01.03.2026
Italy	Not yet recruiting	01.03.2026
Spain	Not yet recruiting	01.03.2026

Trial locations

Investigated drugs:

T1695 is an eye drop suspension being tested in this trial. It is given to treat vernal keratoconjunctivitis, which is a type of eye inflammation that affects the surface of the eye. This medication is applied directly to the eyes to help reduce inflammation and improve symptoms.

Ciclosporin is an eye drop emulsion used to treat eye inflammation. It works by reducing the immune system’s activity in the eyes, which helps decrease swelling and irritation. This medication is commonly used for various inflammatory eye conditions and is applied directly to the eyes.

Vernal Keratoconjunctivitis – Vernal keratoconjunctivitis is an eye condition that affects the outer surface of the eye, specifically the conjunctiva and cornea. It is a chronic inflammatory disorder that typically occurs in children and young adults, often appearing seasonally during warm weather. The condition causes the development of large bumps called papillae on the inner surface of the upper eyelids. Patients experience symptoms including severe itching, excessive tearing, sensitivity to light, and thick mucous discharge from the eyes. The inflammation can lead to damage of the cornea, including staining and in some cases ulceration. The condition tends to recur periodically and may affect one or both eyes.

Trial ID:

2025-521567-12-00

Protocol code:

LT1695-201

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study Comparing Tacrolimus and Ciclosporin Eye Drops for Children and Adults with Moderate to Severe Vernal Keratoconjunctivitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?