Artificial Tear Run-in
OtherArtificial tear eye drop run-in three times daily (TID) for approximately 14 days.
Recruiting
NCT Number: NCT07548632
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
East West Eye Institute, Aliso Viejo, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
licaminlimab
DrugLicaminlimab eye drops three times daily (TID) for 29 days.
Vehicle of licaminlimab
OtherInert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
Primary outcomes
-
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
Secondary outcomes
-
Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).
Time frame: Day 1 to Day 29
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Oculis
Industry
Registry information
Official study title
A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
Acronym: PREDICT-1
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 23, 2026
- Registry last updated
- Jul 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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