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

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.

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.

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.

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.

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.

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.

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.