A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

Part of paid clinical trials in Aliso Viejo, California.

Sponsor
Oculis
Study ID
NCT07548632
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Dry Eye Disease (DED)

Eligibility Criteria

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

Interventions

  • Artificial Tear Run-in — OTHER
    Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
  • licaminlimab — DRUG
    Licaminlimab eye drops three times daily (TID) for 29 days.
  • Vehicle of licaminlimab — OTHER
    Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.

Study Details

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.

Key Dates

Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: licaminlimab
    60 mg/mL licaminlimab ophthalmic solution
  • Placebo Comparator: Vehicle
    Vehicle of licaminlimab ophthalmic solution

Primary Outcome Measure

Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype [ Time Frame: From Day 1 to Day 29 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
East West Eye InstituteAliso ViejoCalifornia92656-
Orange County OphthalmologyGarden GroveCalifornia92843-
Global Research ManagementGlendaleCalifornia91204-
LoBue Laser and Eye Medical CenterMurrietaCalifornia92562-
Eye Research FoundationNewport BeachCalifornia92664-
North Bay Eye Associates, Inc.PetalumaCalifornia94954-
Vision InstituteColorado SpringsColorado80907-
Segal Drug Trials, Inc.Delray BeachFlorida33484-
Oculus Research, Inc.GarnerNorth Carolina27529-
CORE, IncShelbyNorth Carolina28150-
Scott & Christie and AssociatesCranberry TownshipPennsylvania16066-
Erie Retina ResearchEriePennsylvania16507-
Total Eye Care, PAMemphisTennessee38119-
Piedmont Eye Center, Inc.LynchburgVirginia24502-

Find similar trials in Aliso Viejo, CA

By research site
East West Eye Institute· Aliso Viejo, CAOrange County Ophthalmology· Garden Grove, CAGlobal Research Management· Glendale, CALoBue Laser and Eye Medical Center· Murrieta, CAEye Research Foundation· Newport Beach, CANorth Bay Eye Associates, Inc.· Petaluma, CA

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