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Study on the Safety and Effectiveness of Isocyclosporin A Eye Drops for Adults with Atopic Keratoconjunctivitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Atopic Keratoconjunctivitis (AKC), which affects the eyes and can cause symptoms like itching, redness, and discomfort. The study will test the safety and effectiveness of a medication called Isocyclosporin A, which is administered as eye drops. The trial will compare two different doses of Isocyclosporin A to a placebo, which is a substance with no active medication, to see if the medication can improve symptoms in patients with AKC.

The purpose of the study is to determine if at least one of the doses of Isocyclosporin A is better than the placebo in reducing eye itching. Participants in the study will use the eye drops for four weeks, and their symptoms will be monitored during this time. After the treatment period, there will be a follow-up period of two weeks to continue observing the effects of the medication. The study aims to provide valuable information on how well Isocyclosporin A works for people with AKC and whether it is safe to use.

Throughout the study, participants will be asked to report any changes in their symptoms, such as itching, tearing, and discomfort, as well as any side effects they may experience. The study will also assess the overall quality of life for participants, as well as any changes in their vision. By the end of the study, researchers hope to gather enough data to understand the potential benefits and risks of using Isocyclosporin A for treating Atopic Keratoconjunctivitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial procedures and will need to provide consent. This involves reading and signing a consent form to confirm understanding and agreement to participate.

  2. Step 2

    Baseline assessment

    The patient will undergo a baseline assessment to evaluate their current condition. This includes measuring the ocular itching score using a visual analogue scale and assessing other symptoms such as tearing, discomfort, mucous discharge, and photophobia.

  3. Step 3

    Medication administration

    The patient will be randomly assigned to receive either Isocyclosporin A eye drop solution or a vehicle (placebo).

    The eye drops will be administered twice daily (BID) or four times daily (QID) depending on the assigned group.

    The treatment will last for 4 weeks.

  4. Step 4

    Weekly assessments

    Throughout the 4-week treatment period, the patient will have weekly assessments to monitor changes in ocular symptoms and signs.

    These assessments will include measuring the ocular itching score and other symptoms using standardized scales.

  5. Step 5

    End of treatment assessment

    At the end of the 4-week treatment period, a comprehensive assessment will be conducted to evaluate the mean change from baseline in ocular symptoms and signs.

    The primary focus will be on the change in the ocular itching score.

  6. Step 6

    Follow-up period

    After completing the treatment, the patient will enter a 2-week follow-up period.

    During this time, additional assessments will be conducted to monitor any changes in symptoms and to ensure the patient's safety.

Who can join the trial?

12 criteria

  • Must be a male or female aged 18 years or older.
  • Must have a diagnosis of **Atopic Keratoconjunctivitis (AKC)** in both eyes. This includes an eye itching score of 50 or more on a visual scale and at least one of the following conditions in one eye:
    • Presence of a reaction in the inner eyelid or around the eye.
    • A combined symptom score of 4 or more, which includes symptoms like itching, tearing, eye discomfort, sensitivity to light, and mucous discharge.
    • A score of 2 or more for **superficial punctate keratitis**, which is a type of eye surface damage, measured by a special eye stain test.
    • A redness score of 1 or more in the white part of the eye on a scale of 0 to 3.
    • Must have a good level of vision, with a score of +1.0 logMAR or better in both eyes.
    • If female and able to have children, must have a negative pregnancy test at the start of the study.
    • Must have read, signed, and dated the informed consent form before any study procedures begin.
    • Must be able and willing to follow the study procedures.
    • If using skin treatments for allergies, they must be stable for 30 days before the study and expected to remain stable during the study. These treatments should not be used on the eye surface.
    • If using treatments for **atopic dermatitis** (a type of skin allergy), they must be stable for 30 days before the study and expected to remain stable during the study.
    • If using eye medications for conditions other than AKC, they can be included if the medications are not for allergies, steroids, or certain immune treatments, and have been stable for at least 3 months before the study.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older can join.
  • Patients who do not have Atopic Keratoconjunctivitis (AKC) cannot participate. AKC is a condition that affects the eyes, causing itching and inflammation.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who might need special protection, like children or people with certain disabilities.
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Investigated drugs

Isocyclosporin A Eye Drop Solution is being tested in this clinical trial. It is an eye drop medication designed to help reduce symptoms of atopic keratoconjunctivitis (AKC), a condition that causes inflammation and itching in the eyes. The trial aims to determine if this medication can effectively improve ocular itching in adults with AKC.

What is already known about the treatment

Isocyclosporin A – This medication is administered as an eye drop solution and is currently being studied in clinical trials for its effectiveness in treating atopic keratoconjunctivitis (AKC). It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication is to alleviate ocular itching associated with AKC. At the molecular level, Isocyclosporin A works by modulating the immune response, potentially reducing inflammation in the eye. It is classified pharmacologically as an immunosuppressant.

Investigated diseases

Atopic Keratoconjunctivitis – Atopic keratoconjunctivitis (AKC) is a chronic inflammatory condition affecting the eyes, primarily seen in individuals with a history of atopic dermatitis. It involves both the cornea and the conjunctiva, leading to symptoms such as intense itching, redness, tearing, and discomfort. Over time, the condition can cause thickening of the eyelids and changes in the corneal surface, potentially affecting vision. Patients may also experience mucous discharge and sensitivity to light. The disease often progresses with periods of exacerbation and remission, influenced by environmental factors and allergens. It is considered a rare disease and requires careful management to prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508907-19-00Protocol codeICY0123Estimated enrolment69 patientsSponsorDompe' Farmaceutici S.p.A.

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