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The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSJ-110 Solution | Experimental |
| |
| Placebo Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSJ-110 | Drug | ophthalmic solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Corneal Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining. | Measured over an 8-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer's Tear Test | Schirmer tear test strips are used to measure ocular fluid. | Measured over an 8-week treatment period |
| Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) | EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Contact | 202-734-3400 | clinicaltrials@vandapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Recruiting | Newport Beach | California | 92663 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
ophthalmic solution |
|
| Measured over an 8-week treatment period |
| Vanda Investigational Site | Not yet recruiting | Andover | Massachusetts | 01810 | United States |
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| Vanda Investigational Site | Not yet recruiting | Shelby | North Carolina | 28150 | United States |
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| Vanda Investigational Site | Recruiting | Memphis | Tennessee | 38119 | United States |
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| Vanda Investigational Site | Not yet recruiting | Lynchburg | Virginia | 24502 | United States |
|