Dry Eye Disease (DED)Phase 2/3PREDICT-1NCT07548632
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
A Phase 2/3 study testing Artificial Tear Run-in and licaminlimab in people with Dry Eye Disease (DED), run by Oculis at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Artificial Tear Run-in and licaminlimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 14 sitesUnited States
- Study dates
- 16 Apr 2026to Dec 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of Dry Eye Disease in the past 6 months
- Use of over-the-counter tears
- Must agree to genotype testing
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 12 recruiting
- Recruiting
East West Eye Institute
Aliso Viejo, California, 92656
- Recruiting
Vision Institute
Colorado Springs, Colorado, 80907
- Active, not recruiting
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
- Active, not recruiting
Segal Drug Trials, Inc.
Delray Beach, Florida, 33484
- Recruiting
Erie Retina Research
Erie, Pennsylvania, 16507
- Recruiting
Orange County Ophthalmology
Garden Grove, California, 92843
- Recruiting
Oculus Research, Inc.
Garner, North Carolina, 27529
- Recruiting
Global Research Management
Glendale, California, 91204
- Recruiting
Piedmont Eye Center, Inc.
Lynchburg, Virginia, 24502
- Recruiting
Total Eye Care, PA
Memphis, Tennessee, 38119
- Recruiting
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
- Recruiting
Eye Research Foundation
Newport Beach, California, 92664
- Recruiting
North Bay Eye Associates, Inc.
Petaluma, California, 94954
- Recruiting
CORE, Inc
Shelby, North Carolina, 28150
About this study
Official title: A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Artificial Tear Run-in, licaminlimab, Vehicle of licaminlimab
- Keywords
- licaminlimab, OCS-02, PREDICT-1, genotype based development, Eye drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Tear Run-inOther
Artificial tear eye drop run-in three times daily (TID) for approximately 14 days.
licaminlimabDrug
Licaminlimab eye drops three times daily (TID) for 29 days.
Vehicle of licaminlimabOther
Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days.
| Study group | Role | What they receive |
|---|---|---|
| licaminlimab | Experimental | 60 mg/mL licaminlimab ophthalmic solution Receives: Other: Artificial Tear Run-in; Drug: licaminlimab |
| Vehicle | Placebo comparator | Vehicle of licaminlimab ophthalmic solution Receives: Other: Artificial Tear Run-in; Other: Vehicle of licaminlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype
Measured: From Day 1 to Day 29
Secondary outcomes (1)
Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start16 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548632
- Sponsor's protocol ID
- LC-3301
- Acronym
- PREDICT-1
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided