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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental licaminlimab |
60 mg/mL licaminlimab ophthalmic solution |
|
|
Placebo Comparator Vehicle |
Vehicle of licaminlimab ophthalmic solution |
|
Recruiting Locations
Global Research Management
Glendale, California 91204
Glendale, California 91204
Eye Research Foundation
Newport Beach, California 92664
Newport Beach, California 92664
Vision Institute
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Oculus Research, Inc.
Garner, North Carolina 27529
Garner, North Carolina 27529
Scott & Christie and Associates
Cranberry Township, Pennsylvania 16066
Cranberry Township, Pennsylvania 16066
Total Eye Care, PA
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Piedmont Eye Center, Inc.
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
More Details
- NCT ID
- NCT07548632
- Status
- Recruiting
- Sponsor
- Oculis