An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: DFL24498; Other: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 417
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI); Phone Number: +39 02 583 831

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFL24498; Participants will receive DFL24498 opthalmic solution administered topically in both eyes.	Drug: DFL24498; One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
Placebo Comparator: Vehicle; Participants will receive vehicle opthalmic solution administered topically in both eyes.	Other: Vehicle; One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal fluorescein staining (CFS) assessed by National Eye Institute (NEI) scale (0 to 15) in the Study Eye	Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. The CFS is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores five corneal zones from 0 to 3 (total corneal score 0-15) with higher scores indicating more extensive staining.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in ocular dryness symptom assessed by the global score of the Symptom Assessment in Dry Eye (SANDE) questionnaire	The SANDE questionnaire includes 2 VAS questions that measure the frequency and severity of DED (each scored 0-100). The global score (0-100) is calculated by multiplying the frequency score by the severity score and obtaining the square root.	Baseline to Week 12]
Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye.	Fluorescein will be applied to the inferior fornix of the palpebral conjunctiva of each eye. To avoid the phenomenon of quenching, staining will be assessed within 1 to 4 minutes from fluorescein instillation. Corneal fluorescein staining is performed at the slit lamp with blue (cobalt) light. The staining is graded using the NEI scale, which scores six conjunctival zones from 0 to 3 (total conjunctival score 0-18) with higher scores indicating more extensive staining.	Baseline to Week 12
Number of participants reporting treatment-emergent adverse events	An adverse event is any untoward medical occurrence in a clinical study participant, associated with the use of study treatment, whether or not it is considered related to the study treatment. Any adverse events occurring or worsening after the first administration of investigational product will be classified as "treatment-emergent" adverse events.	Up to Week 14
Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye	Before the external ocular examination and post BCVA, the Schirmer I test is performed without anesthesia to measure the wetting of the strip over 5 minutes, and the moistened length is recorded in millimeters (mm).	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Dompé Farmaceutici S.p.A

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): February 7, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Ocular discomfort; DFL24498; Eye dryness; Topical ophthalmic solution
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctival Diseases; Dry Eye Syndromes; Xerophthalmia
• Other Study ID Numbers: ICY-DED-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes