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New eye drops aim to stop itching and eye damage from severe allergies

NCT ID NCT07395232

Symptom relief Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests DFL24498 eye drops in 138 adults with atopic keratoconjunctivitis (AKC), a severe allergic eye condition. The drops are given twice daily for 12 weeks to see if they reduce eye itching and corneal damage compared to a placebo. Participants must have AKC in both eyes and other allergic conditions like eczema or asthma.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DFL24498 eye drop solution
What this could lead to
If successful, this could provide a new treatment option to ease severe eye itching and surface damage in people with AKC.
What could go wrong
This is still an early Phase 3 trial with only 138 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Men or women aged ≥ 18 and ≤ 65 years of age. 2. Diagnosis of AKC in both eyes, including the presence or medical history of the following: 1. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND 2. chronic allergic blepharoconjunctivitis and/or keratoconjunctivitis. 3. Ocular itching of at least 50 as assessed by VAS scale. 4. Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye. 5. A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15). 6. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method. Exclusion Criteria: Participants will be excluded if any of the following criteria apply: 1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments. 2. Evidence of an active ocular infection in either eye. 3. Intraocular inflammation defined as anterior chamber flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye. 4. Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa). 5. Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma. 6. Participants that are anatomically monocular. 7. Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study. Note: Additional protocol defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

atopic keratoconjunctivitis Bronchiolitis Obliterans Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic keratoconjunctivitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, 37134, Italy

  • Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Baylor University Jamail Specialty Care Center- Alkek Eye Center- Ophthalmology

    RECRUITING

    Houston, Texas, 77030, United States

  • Bowden Eye Associates - Southside Location

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clayton Eye Clinical Research

    RECRUITING

    Morrow, Georgia, 30260, United States

  • Duke Eye Center - Ophthalmology

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fondazione Policlinico Universitario Campus Bio-Medico

    RECRUITING

    Roma, 00128, Italy

  • Fundación de Oftalmología Médica de la Comunitat Valenciana (FOM)

    RECRUITING

    Valencia, 46015, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola UO Oftalmologia

    RECRUITING

    Bologna, 40138, Italy

  • METAVISION ARRUZAFA S.L. (Hospital Arruzafa)

    RECRUITING

    Córdoba, 14012, Spain

  • Miranza Galicia

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • NYU Langone Health - Eye Center

    RECRUITING

    New York, New York, 10017, United States

  • OBA - Universidad de Valladolid

    RECRUITING

    Valladolid, 47011, Spain

  • Ophthalmology Associates

    RECRUITING

    St Louis, Missouri, 63131, United States

  • Ospedale SS Annunziata, ASL 2 Lanciano Vasto Chieti

    RECRUITING

    Chieti, 66100, Italy

  • Total Eye Care, PA

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute

    RECRUITING

    Miami, Florida, 33136, United States