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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Dompé Farmaceutici S.p.A
Study ID
NCT07503886
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dry Eye Disease (DED)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 31, 2026
Start date
May 12, 2026
Status verified
Jun 2026
Primary completion
Jan 24, 2027
Completion
Feb 7, 2027

Study Design

Enrollment
417 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

  • Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
    +39 02 583 831

Locations (24)

FacilityCityStateZIPSite coordinators
Arizona Eye CenterChandlerArizona85224-
Canyon City EyecareAzusaCalifornia91702-
Global Research Management, Inc.GlendaleCalifornia91204-
United Medical Research InstituteInglewoodCalifornia90301-
LoBue Laser and Eye Medical CenterMurrietaCalifornia82562-
Eye Research FoundationNewport BeachCalifornia92663-
NVision Clinical Research, LLCTorranceCalifornia90505-
Shettle Eye Research, Inc.LargoFlorida33773-
University of South Florida - Marshall Student CenterTampaFlorida33612-
Clayton Eye Clinical ResearchMorrowGeorgia30260-
Price Vision Group / Cornea Research Foundation of AmericaIndianapolisIndiana46260-
Minnesota Eye ConsultantsMinnetonkaMinnesota55305-
Tekwani Vision CenterSt LouisMissouri63128-
Comprehensive Eye Care, Ltd.WashingtonMissouri63090-
Asheville Eye Associates - Regional Medical ParkAshevilleNorth Carolina28803-
Oculus Research, Inc.GarnerNorth Carolina27529-
Core, Inc.ShelbyNorth Carolina28150-
Cincinnati Eye InstituteMasonOhio45040-
Scott & Christie and Associates, PCCranberry TownshipPennsylvania16066-
Total Eye Care, PA - MemphisMemphisTennessee38119-
Houston Eye AssociatesHoustonTexas77025-
Lake Travis Eye and Laser CenterLakewayTexas78738-
Alpine Research Organization, Inc.ClintonUtah84015-
Piedmont Eye CenterLynchburgVirginia24502-

Find similar trials in Chandler, AZ

By research site
Arizona Eye Center· Chandler, AZCanyon City Eyecare· Azusa, CAGlobal Research Management, Inc.· Glendale, CAUnited Medical Research Institute· Inglewood, CALoBue Laser and Eye Medical Center· Murrieta, CAEye Research Foundation· Newport Beach, CA

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