Dry Eye Disease (DED)
Conditions
Keywords
licaminlimab, OCS-02, PREDICT-1, genotype based development, Eye drops
Brief summary
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.
Interventions
OTHERArtificial Tear Run-in
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
DRUGlicaminlimab
Licaminlimab eye drops three times daily (TID) for 29 days.
OTHERVehicle of licaminlimab
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Sponsors
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Physician diagnosis of Dry Eye Disease in the past 6 months * Use of over-the-counter tears * Must agree to genotype testing Key
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype | From Day 1 to Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype). | Day 1 to Day 29 |
Countries
United States
Contacts
CONTACTOculis Chief Development Officer
Outcome results
None listed