A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

Purpose

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.

Condition

  • Dry Eye Disease (DED)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Physician diagnosis of Dry Eye Disease in the past 6 months - Use of over-the-counter tears - Must agree to genotype testing

Exclusion Criteria

  • Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Sponsor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
licaminlimab 		60 mg/mL licaminlimab ophthalmic solution
  • Other: Artificial Tear Run-in
    Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
  • Drug: licaminlimab
    Licaminlimab eye drops three times daily (TID) for 29 days.
Placebo Comparator
Vehicle 		Vehicle of licaminlimab ophthalmic solution
  • Other: Artificial Tear Run-in
    Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
  • Other: Vehicle of licaminlimab
    Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.

Recruiting Locations

East West Eye Institute
Aliso Viejo, California 92656

Orange County Ophthalmology
Garden Grove, California 92843

Global Research Management
Glendale, California 91204

LoBue Laser and Eye Medical Center
Murrieta, California 92562

Eye Research Foundation
Newport Beach, California 92664

North Bay Eye Associates, Inc.
Petaluma, California 94954

Vision Institute
Colorado Springs, Colorado 80907

Segal Drug Trials, Inc.
Delray Beach, Florida 33484

Oculus Research, Inc.
Garner, North Carolina 27529

CORE, Inc
Shelby, North Carolina 28150

Scott & Christie and Associates
Cranberry Township, Pennsylvania 16066

Erie Retina Research
Erie, Pennsylvania 16507

Total Eye Care, PA
Memphis, Tennessee 38119

Piedmont Eye Center, Inc.
Lynchburg, Virginia 24502

More Details

Status
Recruiting
Sponsor
Oculis

Study Contact

Oculis Chief Development Officer
617 928 5886
info@oculis.com