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A study testing DFL24498 eye drop solution to improve eye itching in adults with atopic keratoconjunctivitis

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study involves people who have Atopic Keratoconjunctivitis, which is a long-lasting eye condition that causes irritation and inflammation of the surface of the eye and the inside of the eyelids. This condition is linked to other allergic problems such as skin allergies, asthma, or hay fever, and it can cause symptoms like severe itching, redness, tearing, sensitivity to light, and mucus discharge from the eyes. The study will test an investigational eye drop solution called DFL24498, which contains Isocyclosporin A as the active ingredient. Some participants will receive the actual medication while others will receive placebo eye drops that look the same but do not contain the active treatment. The study will also look at the use of dexamethasone eye drops, which is a steroid medication that may be used as a rescue treatment if needed during the study.

The purpose of this study is to confirm whether DFL24498 eye drop solution is effective in reducing eye itching and improving other signs of the condition in adults with Atopic Keratoconjunctivitis after six weeks of treatment. The study will measure how much the itching improves, as well as changes in damage to the clear front part of the eye, which is called the cornea, and redness of the white part of the eye, which is called the conjunctiva. The main goal is to see if the investigational eye drops can help relieve the uncomfortable symptoms that people with this condition experience.

During the study, participants will be randomly assigned to receive either DFL24498 eye drops or placebo eye drops, and neither the participants nor the doctors will know which treatment is being given. The treatment will continue for twelve weeks, with regular visits to check how well the eyes are responding and to monitor for any side effects. At these visits, doctors will examine the eyes, ask about symptoms, and assess the overall condition using various measurement scales. The study will track changes in itching levels, the health of the eye surface, and the degree of redness to determine whether the investigational treatment is working better than placebo.

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

    Treatment period begins

    The treatment phase of the study will last for 6 weeks.

    During this period, one of three possible treatments will be assigned: DFL24498 eye drop solution, Isocyclosporin A eye drops, or placebo eye drops (a solution without active medication).

    The assignment will be randomized, meaning it will be determined by chance, similar to flipping a coin.

    Neither the patient nor the study doctor will know which treatment has been assigned. This is called a double-masked study.

  2. Step 2

    Administration of eye drops

    The assigned eye drop solution must be applied to both eyes as instructed by the study doctor.

    The eye drops are for ophthalmic use, which means they are specifically designed to be applied directly to the eyes.

    The exact dosage, frequency, and timing of administration will be provided by the study team at the beginning of the treatment period.

    The eye drops must be used consistently throughout the entire 6-week treatment period.

  3. Step 3

    Assessment of symptoms at baseline

    At the start of the study, several measurements will be taken to establish a baseline for comparison.

    Ocular itching (eye itching) will be assessed using a visual analog scale, which is a tool that allows the patient to rate the severity of itching on a scale.

    The surface of the eye will be examined using a special dye called fluorescein to check for damage to the cornea (the clear front part of the eye). This is scored using the modified Oxford scale.

    Bulbar conjunctival hyperemia (redness of the white part of the eye) will be measured using the Validated Bulbar Redness scale, which rates redness on a scale from 0 to 100.

    A composite symptoms score will be calculated based on five symptoms: itching, tearing, eye discomfort, sensitivity to light, and mucous discharge. Each symptom is rated from 0 to 3, and the total score can range from 0 to 15.

  4. Step 4

    Regular follow-up visits during treatment

    Throughout the 6-week treatment period, regular visits to the study site will be required.

    During these visits, the study team will monitor the condition of the eyes and assess any changes in symptoms.

    The same measurements taken at baseline will be repeated at these visits to track progress.

    Any side effects or concerns should be reported to the study team during these visits.

  5. Step 5

    Final assessment at week 6

    At the end of the 6-week treatment period, a final assessment will be conducted.

    The primary measurement will be the change in ocular itching from the baseline visit, assessed using the visual analog scale.

    Additional measurements will include the change in corneal staining (damage to the cornea) using the modified Oxford scale.

    The change in redness of the white part of the eye will also be measured using the Validated Bulbar Redness scale.

    These measurements will help determine the effectiveness of the treatment received.

  6. Step 6

    Completion of the study

    After the final assessment at week 6, participation in the treatment phase of the study will be complete.

    Any additional follow-up procedures or visits, if required, will be explained by the study team.

    The study doctor will provide information about any further care or treatment options after the study ends.

Who can join the trial?

11 criteria

  • You must be between 18 and 65 years old
  • You must have a diagnosis of Atopic Keratoconjunctivitis, which is a long-term eye condition causing inflammation and irritation, in both eyes
  • You must have or have had in the past another atopic condition, which means an allergic condition such as skin inflammation called atopic dermatitis, skin irritation around the eyes called periocular eczema, asthma, or allergic rhinitis which is an allergic reaction in the nose
  • You must have long-lasting allergic blepharoconjunctivitis, which means inflammation of the eyelids and the surface of the eye, or keratoconjunctivitis, which is inflammation that also affects the clear front part of the eye called the cornea
  • You must have eye itching with a score of at least 50 on a scale from 0 to 100
  • You must have damage to the cornea, which is the clear front surface of your eye, shown by a special staining test with a score of at least grade 1
  • You must have redness in the white part of your eye with a score of at least 40 on a scale from 0 to 100 in the same eye that has corneal damage
  • You must have a combined symptom score of at least 5 out of 15, which includes itching, tearing, eye discomfort, sensitivity to light, and mucous discharge
  • If you are a woman who can become pregnant, you must have a negative pregnancy test at two visits and agree to use an acceptable method of birth control during the study
  • You must be willing and able to read, sign, and date the informed consent form before any study activities begin
  • You must be able and willing to follow all study requirements and attend scheduled visits

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed information about what conditions or situations would prevent participation, the specific reasons for exclusion cannot be listed
  • Generally, clinical trials may exclude patients based on other eye diseases, certain medications being taken, pregnancy, or other health conditions, but these specific details are not available in the provided information
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Investigated drugs

  • DFL24498

    is an eye drop solution being tested to see if it can help reduce eye itching and other symptoms in people with atopic keratoconjunctivitis, which is a type of eye inflammation and allergy. This medication is applied directly to the eyes as drops.

  • Vehicle

    is a placebo eye drop solution that looks like the real medication but contains no active medicine. It is used as a comparison to help researchers understand if the real medication is working better than no treatment.

What is already known about the treatment

DFL24498 – DFL24498 is an eye drop solution that is currently being studied in Phase 3 clinical trials to treat atopic keratoconjunctivitis, which is a severe allergic condition affecting the eyes that causes itching, redness, and inflammation. The medication is applied directly to the eyes as drops and works by targeting the underlying allergic and inflammatory processes at the cellular level to reduce symptoms, particularly eye itching. In the clinical trial, it is being compared against a vehicle-controlled solution (a placebo eye drop without the active ingredient) to demonstrate its effectiveness and safety over a 6-week treatment period in adult patients.

Investigated diseases

Atopic Keratoconjunctivitis – Atopic keratoconjunctivitis is a chronic inflammatory condition affecting both the conjunctiva and cornea of the eyes. This disease typically develops in individuals who have a history of atopic conditions such as eczema or asthma. The condition causes persistent itching of the eyes, which is often one of the most bothersome symptoms for patients. The inflammation leads to redness of the conjunctiva, the clear membrane covering the white part of the eye. Over time, the cornea, which is the clear front surface of the eye, can become damaged and show signs of surface irregularities. The disease tends to have periods of worsening symptoms followed by periods of improvement, creating a chronic pattern that affects daily activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522291-83-00Protocol codeICY-AKC-301Estimated enrolment161 patientsSponsorDompe' Farmaceutici S.p.A.

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