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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| licaminlimab (OCS-02) | Experimental | 60 mg/mL licaminlimab ophthalmic solution |
|
| Vehicle | Placebo Comparator | Vehicle of licaminlimab (OCS-02) ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| licaminlimab | Drug | ophthalmic solution 60 mg/mL Subjects will be randomized to receive licaminlimab eye drops three times daily (TID) for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Klier, MD, MPH | Oculis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oculis Investigative Site | Newport Beach | California | 92663 | United States | ||
| Oculis Investigative Site |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| vehicle of OCS-02 | Other | inert ophthalmic solution vehicle of OCS-02 Subjects will be randomized to receive vehicle eye drops three times daily (TID) for 6 weeks. |
|
| Artificial tears | Other | 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. |
|
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Oculis Investigative Site | Shelby | North Carolina | 28150 | United States |
| Oculis Investigative Site | Erie | Pennsylvania | 16507 | United States |
| Oculis Investigative Site | Memphis | Tennessee | 38119 | United States |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |