Actively Recruiting
An Eight-Week, Double-Masked, Randomized, Placebo-Controlled Study of VSJ-110 Eye Drops for Dry Eye
Led by Vanda Pharmaceuticals · Updated on 2025-09-17
160
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of VSJ-110, an eye drop solution, compared to a placebo in treating dry eye. This phase 2 clinical trial aims to provide important information about how well VSJ-110 works and how safe it is for people with dry eye over an eight-week period. The study is randomized and double-masked, meaning neither participants nor researchers know who receives the treatment or placebo during the trial. Participants will be randomly assigned to receive either the VSJ-110 ophthalmic solution or a placebo solution. Both treatments are delivered as eye drops, and the study lasts for eight weeks. The trial is designed to closely monitor the participants' response to treatment and any side effects that may occur during this time. Throughout the study, participants will attend scheduled visits where various assessments will be performed. These include measuring corneal staining, which shows eye surface damage, and performing Schirmer's Tear Test to evaluate tear production. Participants will also report their eye dryness using a visual scale. The research team will monitor safety and collect data to evaluate the outcomes over the full eight weeks of treatment.
CONDITIONS
Brief Title
An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Use of any of the disallowed medications during the washout and study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive VSJ-110 or placebo eye drops to evaluate their safety and effectiveness in treating dry eye.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 5 locations
1
Vanda Investigational Site
Newport Beach, California, United States, 92663
Actively Recruiting
2
Vanda Investigational Site
Andover, Massachusetts, United States, 01810
Not Yet Recruiting
3
Vanda Investigational Site
Shelby, North Carolina, United States, 28150
Not Yet Recruiting
4
Vanda Investigational Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
5
Vanda Investigational Site
Lynchburg, Virginia, United States, 24502
Not Yet Recruiting
Research Team
V
Vanda Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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