Dry Eye DiseasePhase 2RELIEFNCT05896670
Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease
A Phase 2 study testing licaminlimab and Artificial tears in people with Dry Eye Disease, run by Oculis at 5 sites in United States.
Trial summary
The goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- licaminlimab and Artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Nov 2023to 27 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Be at least 18 years of age.
- Provide written informed consent.
- Be willing and able to comply with all study procedures.
- Have a history of dry eye disease for at least 6 months prior to Visit 1.
Who cannot join
- Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at Visit 1 or Visit 2.
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.
- Additional inclusion/exclusion criteria apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Oculis Investigative Site
Colorado Springs, Colorado, 80907
Oculis Investigative Site
Erie, Pennsylvania, 16507
Oculis Investigative Site
Memphis, Tennessee, 38119
Oculis Investigative Site
Newport Beach, California, 92663
Oculis Investigative Site
Shelby, North Carolina, 28150
About this study
Official title: A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease
The goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.
Read the detailed description
This is a Phase 2b, multicenter, randomized, double-masked, vehicle-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- licaminlimab, vehicle of OCS-02, Artificial tears
- Keywords
- Ophthalmology, Topical Ophthalmic Solution, Eye Drop, DED
- 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.
licaminlimabDrug
Also called OCS-02
ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.
vehicle of OCS-02Other
inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.
Artificial tearsOther
Subjects who quality after an initial screening were entered into a run-in phase where they received artificial tears to use three times daily (TID) for approximately 14 days.
| Study group | Role | What they receive |
|---|---|---|
| licaminlimab (OCS-02) | Experimental | 60 mg/mL licaminlimab ophthalmic solution Receives: Drug: licaminlimab; Other: Artificial tears |
| Vehicle | Placebo comparator | Vehicle of licaminlimab (OCS-02) ophthalmic solution Receives: Other: vehicle of OCS-02; Other: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study
Measured: Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start29 Nov 2023
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Sharon Klier, MD, MPH, Study director, Oculis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896670
- Sponsor's protocol ID
- LC-201
- Acronym
- RELIEF
- Status last verified
- Jun 2025
- First submitted
- 31 May 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05896670
- Acronym / sponsor ID
- RELIEF / LC-201
- Conditions
- Dry Eye Disease
- Keywords
- Ophthalmology, Topical Ophthalmic Solution, Eye Drop, DED
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- OculisIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 9 Jun 2023 (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 goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.
Detailed description
This is a Phase 2b, multicenter, randomized, double-masked, vehicle-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| licaminlimab (OCS-02) | Experimental | Drug: licaminlimab, Other: Artificial tears60 mg/mL licaminlimab ophthalmic solution |
| Vehicle | Placebo comparator | Other: vehicle of OCS-02, Other: Artificial tearsVehicle of licaminlimab (OCS-02) ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age.
- Provide written informed consent.
- Be willing and able to comply with all study procedures.
- Have a history of dry eye disease for at least 6 months prior to Visit 1.
Key exclusion criteria (4 listed)
- Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at Visit 1 or Visit 2.
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.
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 |
|---|---|---|
| licaminlimabAlso: OCS-02ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks. | Drug | licaminlimab (OCS-02) |
| vehicle of OCS-02inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks. | Other | Vehicle |
| Artificial tearsSubjects who quality after an initial screening were entered into a run-in phase where they received artificial tears to use three times daily (TID) for approximately 14 days. | Other | Vehicle, licaminlimab (OCS-02) |
Primary outcome
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
Time frame: Baseline to Day 43
Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sharon Klier, MD, MPH study director
Oculis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing licaminlimab and Artificial tears in people with Dry Eye Disease, run by Oculis at 5 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease (time frame: Baseline to Day 43). 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 2 Jul 2025.