Dry Eye Disease (DED)Phase 2NCT07503886
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
A Phase 2 study testing DFL24498 in people with Dry Eye Disease (DED), run by Dompé Farmaceutici S.p.A at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- DFL24498
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 24 sitesUnited States
- Study dates
- 12 May 2026to 12 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) contact
24 sites in 1 country
United States24 sites, 24 recruiting
- Not yet recruiting
Asheville Eye Associates - Regional Medical Park
Asheville, North Carolina, 28803
- Recruiting
Canyon City Eyecare
Azusa, California, 91702
- Recruiting
Arizona Eye Center
Chandler, Arizona, 85224
- Not yet recruiting
Alpine Research Organization, Inc.
Clinton, Utah, 84015
- Recruiting
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
- Recruiting
Oculus Research, Inc.
Garner, North Carolina, 27529
- Recruiting
Global Research Management, Inc.
Glendale, California, 91204
- Not yet recruiting
Houston Eye Associates
Houston, Texas, 77025
- Recruiting
Price Vision Group / Cornea Research Foundation of America
Indianapolis, Indiana, 46260
- Recruiting
United Medical Research Institute
Inglewood, California, 90301
- Recruiting
Lake Travis Eye and Laser Center
Lakeway, Texas, 78738
- Not yet recruiting
Shettle Eye Research, Inc.
Largo, Florida, 33773
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502
- Not yet recruiting
Cincinnati Eye Institute
Mason, Ohio, 45040
- Recruiting
Total Eye Care, PA - Memphis
Memphis, Tennessee, 38119
- Not yet recruiting
Minnesota Eye Consultants
Minnetonka, Minnesota, 55305
- Recruiting
Clayton Eye Clinical Research
Morrow, Georgia, 30260
- Not yet recruiting
LoBue Laser and Eye Medical Center
Murrieta, California, 82562
- Recruiting
Eye Research Foundation
Newport Beach, California, 92663
- Not yet recruiting
Core, Inc.
Shelby, North Carolina, 28150
- Not yet recruiting
Tekwani Vision Center
St Louis, Missouri, 63128
- Not yet recruiting
University of South Florida - Marshall Student Center
Tampa, Florida, 33612
- Recruiting
NVision Clinical Research, LLC
Torrance, California, 90505
- Not yet recruiting
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
Official title: 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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- DFL24498, Vehicle
- Keywords
- Dry Eye Disease, DFL24498, Ocular discomfort, Eye dryness, Topical ophthalmic solution
- Medical subject headings
- Dry Eye Syndromes, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFL24498Drug
One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.
VehicleOther
One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DFL24498 | Experimental | Participants will receive DFL24498 opthalmic solution administered topically in both eyes. Receives: Drug: DFL24498 |
| Vehicle | Placebo comparator | Participants will receive vehicle opthalmic solution administered topically in both eyes. Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline to Week 12]
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).
Measured: 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.
Measured: 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.
Measured: Up to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start12 May 2026
- Primary completion27 Dec 2026 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503886
- Sponsor's protocol ID
- ICY-DED-201
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No