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New eye drops aim to soothe dry eye sufferers

NCT ID NCT07503886

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new eye drop called DFL24498 in people with dry eye disease. About 417 adults will use the drops four times a day for 12 weeks. Researchers will check if the drops improve eye surface health and reduce dryness symptoms compared to a placebo.

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 drops
What this could lead to
If successful, this could lead to a new prescription eye drop that reduces dry eye symptoms and eye surface damage.
What could go wrong
This is an early Phase 2 trial, so the drops may not work better than placebo. Side effects are possible, and results may not apply to all dry eye patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 417 people

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

Started

May 2026

Expected to finish

Feb 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 years and older

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.

Key Inclusion Criteria: * A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye). * The global score of the SANDE questionnaire ≥ 30 * DED in at least one eye which is characterized by the following clinical features: 1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and 2. Total CFS grade ≥ 4 assessed by the NEI grading system, and 3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds. * Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment. * Only participants who satisfy all informed consent requirements will be included in the study. Key Exclusion Criteria: * 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. * Evidence of an active ocular infection in either eye. * Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening. * Intraocular inflammation defined as anterior chamber cell or flare \> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye. * Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome xerophthalmia

As listed by the trial registrant

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

Dry eye disease (DED)

How to take part

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

  1. The places running it

    24 sites. 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

  • Alpine Research Organization, Inc.

    NOT_YET_RECRUITING

    Clinton, Utah, 84015, United States

  • Arizona Eye Center

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Asheville Eye Associates - Regional Medical Park

    NOT_YET_RECRUITING

    Asheville, North Carolina, 28803, United States

  • Canyon City Eyecare

    RECRUITING

    Azusa, California, 91702, United States

  • Cincinnati Eye Institute

    NOT_YET_RECRUITING

    Mason, Ohio, 45040, United States

  • Clayton Eye Clinical Research

    RECRUITING

    Morrow, Georgia, 30260, United States

  • Comprehensive Eye Care, Ltd.

    NOT_YET_RECRUITING

    Washington, Missouri, 63090, United States

  • Core, Inc.

    NOT_YET_RECRUITING

    Shelby, North Carolina, 28150, United States

  • Eye Research Foundation

    RECRUITING

    Newport Beach, California, 92663, United States

  • Global Research Management, Inc.

    RECRUITING

    Glendale, California, 91204, United States

  • Houston Eye Associates

    NOT_YET_RECRUITING

    Houston, Texas, 77025, United States

  • Lake Travis Eye and Laser Center

    RECRUITING

    Lakeway, Texas, 78738, United States

  • LoBue Laser and Eye Medical Center

    NOT_YET_RECRUITING

    Murrieta, California, 82562, United States

  • Minnesota Eye Consultants

    NOT_YET_RECRUITING

    Minnetonka, Minnesota, 55305, United States

  • NVision Clinical Research, LLC

    RECRUITING

    Torrance, California, 90505, United States

  • Oculus Research, Inc.

    RECRUITING

    Garner, North Carolina, 27529, United States

  • Piedmont Eye Center

    RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Price Vision Group / Cornea Research Foundation of America

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Scott & Christie and Associates, PC

    RECRUITING

    Cranberry Township, Pennsylvania, 16066, United States

  • Shettle Eye Research, Inc.

    NOT_YET_RECRUITING

    Largo, Florida, 33773, United States

  • Tekwani Vision Center

    NOT_YET_RECRUITING

    St Louis, Missouri, 63128, United States

  • Total Eye Care, PA - Memphis

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • United Medical Research Institute

    RECRUITING

    Inglewood, California, 90301, United States

  • University of South Florida - Marshall Student Center

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

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