Study on Ciclosporin for Treating Atopic Keratoconjunctivitis in Adults

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What is this study about?

This clinical trial is focused on studying the treatment of Atopic Keratoconjunctivitis, a condition that causes inflammation in the eyes, often associated with allergies. The treatment being tested is called Ikervis, which is an eye drop containing the active ingredient Ciclosporin. This medication is typically used to treat severe inflammation of the cornea, the clear front part of the eye, in adults with dry eye disease. In this study, Ikervis will be used to see if it can help people with Atopic Keratoconjunctivitis.

The purpose of the study is to assess how effective Ikervis is when used four times a day for four months. Participants will be randomly assigned to receive either Ikervis or a placebo. The study will involve regular check-ups to monitor the condition of the eyes and any changes in symptoms. The main focus will be on changes in eye redness, but other aspects like eye comfort and tear production will also be evaluated.

Participants will be asked to use the eye drops daily and attend scheduled appointments for assessments. The study aims to provide valuable information on whether Ikervis can be a beneficial treatment for those suffering from Atopic Keratoconjunctivitis, potentially offering relief from the symptoms associated with this eye condition.

1 joining the study

Participation begins after meeting specific criteria, including being at least 18 years old and having atopic dermatitis and keratoconjunctivitis.

The ability to attend scheduled appointments is required.

2 initial assessment

An initial assessment is conducted to evaluate the condition of the eyes, including the presence of posterior blepharitis and signs of conjunctivitis.

Measurements such as the Bulbar Redness score and corneal fluorescein staining are taken.

3 medication administration

The medication Ikervis is administered as eye drops, with a concentration of 1 mg/mL.

The drops are applied to the eyes four times daily for a duration of four months.

4 follow-up assessments

Regular follow-up assessments are conducted to monitor changes in eye condition.

Primary focus is on the change in the Bulbar Redness score from the start to the end of the four-month period.

5 secondary evaluations

Additional evaluations include measuring ocular discomfort, ocular surface disease index, and tear osmolarity.

Other assessments involve tear meniscus height, non-invasive tear break-up time, and meibography.

6 completion of the trial

The trial concludes after the four-month treatment period.

Final assessments are conducted to evaluate the overall effectiveness of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Have atopic dermatitis, which is a skin condition, graded as at least mild. This means:
- An EASI-score of at least 1.1 from a dermatologist visit within the last 6 months. EASI stands for Eczema Area and Severity Index, a way to measure the severity of eczema.
- Or a POEM-score of 3 if there were no dermatologist visits in the last 6 months. POEM stands for Patient-Oriented Eczema Measure, a questionnaire to assess eczema symptoms.
Have atopic keratoconjunctivitis, an eye condition, with all of the following at the time of joining:
- At least mild posterior blepharitis or meibomian gland dysfunction. This means having at least one blocked gland in the upper eyelids.
- Signs of conjunctivitis, which is redness in the white part of the eye, with a score of 2 or more.
- Corneal fluorescein staining score between 1 and 4. This is a test to check for damage on the surface of the eye.
Must be able to attend and return for scheduled study appointments.

Who Cannot Join the Study?

Patients who are not diagnosed with Atopic Keratoconjunctivitis cannot participate. This is a condition that affects the eyes, causing inflammation and discomfort.
Patients who are younger than 4 years old or older than 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rvgavtyrheeboo	Glostrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Ciclosporin

Ikervis is an eye drop medication used in this trial to treat atopic keratoconjunctivitis, a condition that causes inflammation of the eye. The trial aims to evaluate how effective Ikervis is when used regularly over a period of four months.

Atopic Keratoconjunctivitis – Atopic Keratoconjunctivitis is a chronic inflammatory condition affecting the eyes, primarily seen in individuals with a history of atopic dermatitis or other allergic conditions. It involves inflammation of both the cornea and the conjunctiva, leading to symptoms such as redness, itching, and discomfort in the eyes. Over time, the condition can cause thickening of the eyelids and changes in the corneal surface, potentially affecting vision. Patients may experience increased sensitivity to light and a sensation of grittiness or burning in the eyes. The disease often follows a pattern of flare-ups and remissions, with symptoms varying in intensity.

Trial ID:

2022-500633-92-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ciclosporin for Treating Atopic Keratoconjunctivitis in Adults

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