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

NCT07503886 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: ICY-DED-201
• Study Type: interventional
• Target: 417
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in ocular dryness symptom assessed by the global score of the Symptom Assessment in Dry Eye (SANDE) questionnaire

  Baseline to Week 12]

• Change from baseline in tear production assessed by Schirmer I test without anesthesia in the Study Eye

  Baseline to Week 12

• Change from baseline; in conjunctival fluorescein staining assessed by NEI scale (0 to 18) in the Study Eye.

  Baseline to Week 12

• Number of participants reporting treatment-emergent adverse events

  Up to Week 14

Study Arms (2)

DFL24498

EXPERIMENTAL

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

Drug: DFL24498

Vehicle

PLACEBO COMPARATOR

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

Other: Vehicle

Interventions

DFL24498 DRUG

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

DFL24498

Vehicle OTHER

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

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Schirmer I test without anesthesia \< 10 mm/5 minutes, and
• Total CFS grade ≥ 4 assessed by the NEI grading system, and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Xerophthalmia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Conjunctival Diseases

Central Study Contacts

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

CONTACT

+39 02 583 831

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): February 7, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share