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The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| licaminlimab | Experimental | 60 mg/mL licaminlimab ophthalmic solution |
|
| Vehicle | Placebo Comparator | Vehicle of licaminlimab ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Tear Run-in | Other | Artificial tear eye drop run-in three times daily (TID) for approximately 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype | From Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype). | Day 1 to Day 29 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oculis Chief Development Officer | Contact | 617 928 5886 | info@oculis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East West Eye Institute | Recruiting | Aliso Viejo | California | 92656 | United States | |
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Sponsor
| licaminlimab | Drug | Licaminlimab eye drops three times daily (TID) for 29 days. |
|
| Vehicle of licaminlimab | Other | Inert ophthalmic solution vehicle of licaminlimab, three times daily (TID) for 29 days. |
|
| Orange County Ophthalmology |
| Recruiting |
| Garden Grove |
| California |
| 92843 |
| United States |
| Global Research Management | Recruiting | Glendale | California | 91204 | United States |
| LoBue Laser and Eye Medical Center | Recruiting | Murrieta | California | 92562 | United States |
| Eye Research Foundation | Recruiting | Newport Beach | California | 92664 | United States |
| North Bay Eye Associates, Inc. | Recruiting | Petaluma | California | 94954 | United States |
| Vision Institute | Recruiting | Colorado Springs | Colorado | 80907 | United States |
| Segal Drug Trials, Inc. | Recruiting | Delray Beach | Florida | 33484 | United States |
| Oculus Research, Inc. | Recruiting | Garner | North Carolina | 27529 | United States |
| CORE, Inc | Recruiting | Shelby | North Carolina | 28150 | United States |
| Scott & Christie and Associates | Recruiting | Cranberry Township | Pennsylvania | 16066 | United States |
| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16507 | United States |
| Total Eye Care, PA | Recruiting | Memphis | Tennessee | 38119 | United States |
| Piedmont Eye Center, Inc. | Recruiting | Lynchburg | Virginia | 24502 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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