NCT05896670

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 31, 2023

Last Update Submit

June 25, 2025

Conditions

Dry Eye Disease

Keywords

OphthalmologyTopical Ophthalmic SolutionEye DropDED

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to Day 43

Study Arms (2)

licaminlimab (OCS-02)

EXPERIMENTAL

60 mg/mL licaminlimab ophthalmic solution

Drug: licaminlimabOther: Artificial tears

Vehicle

PLACEBO COMPARATOR

Vehicle of licaminlimab (OCS-02) ophthalmic solution

Other: vehicle of OCS-02Other: Artificial tears

Interventions

licaminlimabDRUG

ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks.

Also known as: OCS-02
licaminlimab (OCS-02)
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.

Vehicle
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.

Vehiclelicaminlimab (OCS-02)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Oculis Investigative Site

Newport Beach, California, 92663, United States

Location

Oculis Investigative Site

Colorado Springs, Colorado, 80907, United States

Location

Oculis Investigative Site

Shelby, North Carolina, 28150, United States

Location

Oculis Investigative Site

Erie, Pennsylvania, 16507, United States

Location

Oculis Investigative Site

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • Sharon Klier, MD, MPH

    Oculis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

November 29, 2023

Primary Completion

March 27, 2024

Study Completion

March 27, 2024

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(5)