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Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease

NCT05896670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

licaminlimab

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

OTHER

vehicle of OCS-02

inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks.

OTHER

Artificial tears

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.

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Oculis

    lead INDUSTRY

Principal Investigators

  • Sharon Klier, MD, MPH · Oculis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-03-27
Completion
2024-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896670 on ClinicalTrials.gov