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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07548632
- Acronym / sponsor ID
- PREDICT-1 / LC-3301
- Conditions
- Dry Eye Disease (DED)
- Keywords
- licaminlimab, OCS-02, PREDICT-1, genotype based development, Eye drops
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- OculisIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| licaminlimab | Experimental | Other: Artificial Tear Run-in, Drug: licaminlimab60 mg/mL licaminlimab ophthalmic solution |
| Vehicle | Placebo comparator | Other: Artificial Tear Run-in, Other: Vehicle of licaminlimabVehicle of licaminlimab ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Tear Run-inArtificial tear eye drop run-in three times daily (TID) for approximately 14 days. | Other | Vehicle, licaminlimab |
| licaminlimabLicaminlimab eye drops three times daily (TID) for 29 days. | Drug | licaminlimab |
| Vehicle of licaminlimabInert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days. | Other | Vehicle |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oculis Chief Development Officer (617 928 5886, info@oculis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.