NCT05896670

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

A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-29
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2023-06-09
• Last updated: 2025-07-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study