Recruiting
Phase 2

DFL24498

Sponsor:

Dompé Farmaceutici S.p.A

Code:

NCT07503886

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DFL24498

Vehicle

Study Details

Brief summary:

This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.

Conditions

Dry Eye Disease (DED)

Study ID

NCT07503886

Start date

May 12, 2026

Status verified date

Jun, 2026

Completion date

Feb 7, 2027

Anticipated

Primary completion date

Jan 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

417 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DFL24498

Participants will receive DFL24498 opthalmic solution administered topically in both eyes.

placebo comparator: Vehicle

Participants will receive vehicle opthalmic solution administered topically in both eyes.

Interventions

DFL24498

One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.

Vehicle

One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

Primary outcome measure

  • Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

+39 02 583 831

Locations

Arizona Eye Center

Recruiting

Chandler, Arizona, United States, 85224

Canyon City Eyecare

Recruiting

Azusa, California, United States, 91702

Global Research Management, Inc.

Recruiting

Glendale, California, United States, 91204

United Medical Research Institute

Recruiting

Inglewood, California, United States, 90301

Eye Research Foundation

Recruiting

Newport Beach, California, United States, 92663

NVision Clinical Research, LLC

Recruiting

Torrance, California, United States, 90505

Clayton Eye Clinical Research

Recruiting

Morrow, Georgia, United States, 30260

Price Vision Group / Cornea Research Foundation of America

Recruiting

Indianapolis, Indiana, United States, 46260

Oculus Research, Inc.

Recruiting

Garner, North Carolina, United States, 27529

Scott & Christie and Associates, PC

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Total Eye Care, PA - Memphis

Recruiting

Memphis, Tennessee, United States, 38119

Lake Travis Eye and Laser Center

Recruiting

Lakeway, Texas, United States, 78738

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

More Information

Sponsor

Dompé Farmaceutici S.p.A

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Dry Eye Disease
  • DFL24498
  • Ocular discomfort
  • Eye dryness
  • Topical ophthalmic solution

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dompé Farmaceutici S.p.A on 2026-06-26.