- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896670
Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Dry Eye Disease (RELIEF)
February 2, 2024 updated by: Oculis
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 suspension is more effective than vehicle in treating signs of dry eye disease.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 2b, multicenter, randomized, double-masked, active-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oculis Study Leader
- Phone Number: +41 21 711 3970
- Email: info@oculis.com
Study Contact Backup
- Name: Ora, Inc. Study Leader
- Phone Number: +1-978-685-8900
Study Locations
-
-
California
-
Newport Beach, California, United States, 92663
- Oculis Investigative Site
-
Contact:
- Oculis Investigator
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80907
- Oculis Investigative Site
-
-
North Carolina
-
Shelby, North Carolina, United States, 28150
- Oculis Investigative Site
-
-
Pennsylvania
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Erie, Pennsylvania, United States, 16507
- Oculis Investigative Site
-
-
Tennessee
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Memphis, Tennessee, United States, 38119
- Oculis Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic suspension
|
ophthalmic suspension 60 mg/mL Subjects will receive licaminlimab eye drops TID for 6 weeks.
All subjects will be assigned artificial tears TID for 2 weeks.
Other Names:
|
Placebo Comparator: Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic suspension
|
inert ophthalmic suspension vehicle of OCS-02 Subjects will receive vehicle eye drops TID for 6 weeks.
All subjects will be assigned artificial tears TID for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
Time Frame: Baseline to Day 43
|
Total corneal staining - change from baseline versus vehicle pre-CAE®, pre-CAE® to post-CAE®, and post-CAE®
|
Baseline to Day 43
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 9, 2023
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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