Recruiting NCT07179055
An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VSJ-110, Placebo.
- Who it may be relevant to
- Registry conditions: Dry Eye. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Eight-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
Overview
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
Interventions
- Drug VSJ-110
ophthalmic solution - Drug Placebo
ophthalmic solution
Primary outcome measures
- Corneal Staining [Time frame: Measured over an 8-week treatment period]
Secondary outcome measures (2)
- Schirmer's Tear Test [Time frame: Measured over an 8-week treatment period]
- Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) [Time frame: Measured over an 8-week treatment period]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Vanda Investigational Site — Newport Beach
- Vanda Investigational Site — Andover
- Vanda Investigational Site — Shelby
- Vanda Investigational Site — Memphis
- Vanda Investigational Site — Lynchburg
Identifiers
NCT: NCT07179055 · VP-VSJ-110-2202