An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
- Registration Number
- NCT07179055
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VSJ-110 Solution VSJ-110 - Placebo Solution Placebo -
- Primary Outcome Measures
Name Time Method Corneal Staining Measured over an 8-week treatment period Corneal Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.
- Secondary Outcome Measures
Name Time Method Schirmer's Tear Test Measured over an 8-week treatment period Schirmer tear test strips are used to measure ocular fluid.
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) Measured over an 8-week treatment period EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort).
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Lynchburg, Virginia, United States
Vanda Investigational Site🇺🇸Lynchburg, Virginia, United StatesVanda PharmaceuticalsContact202-734-3400