Dry Eye Clinical Trial
Official title:
A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Be at least 18 years of age of either gender and any race. - Provide written informed consent and sign the HIPAA form. - Be willing and able to follow all instructions and attend all study visits. Exclusion Criteria: - Use of any of the disallowed medications during the washout and study period. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Vanda Investigational Site | Andover | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Vanda Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Schirmer's Tear Test | Schirmer's Tear Test strips are used to measure ocular fluid. | Measured over a 4-week treatment period | |
| Secondary | Ocular Staining | Ocular 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 a 4-week treatment period | |
| Secondary | 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). | Measured over a 4-week treatment period |
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