Eight-week test of VSJ-110 versus placebo for dry eye
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
This eight-week test will see if VSJ-110 reduces dry eye symptoms better than a placebo in adults with dry eye.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 5 sites (Newport Beach, California and 4 other locations) |
| Trial ID | NCT07179055 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial compares VSJ-110 to a placebo over an eight-week treatment period in adults with dry eye. Participants receive either VSJ-110 or a matching placebo and attend scheduled visits for symptom assessments and safety monitoring. Primary data collected will include changes in dry eye signs and symptoms and adverse event reporting. The trial is being run at multiple Vanda investigational sites in the United States.
Who should consider this trial
Good fit: Adults aged 18 and older with dry eye who can give informed consent, follow study instructions, attend visits, and stop disallowed medications during the washout and study period are ideal candidates.
Not a fit: Patients who cannot discontinue disallowed medications, who fail to meet inclusion criteria, or who have excluded conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If effective and safe, VSJ-110 could provide a new treatment option that reduces symptoms of dry eye.
How similar studies have performed: Other placebo-controlled phase 2 trials of new topical therapies for dry eye have shown mixed results, and while several approved treatments exist, VSJ-110 appears to be a novel compound.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newport Beach, California and 4 other locations
- Vanda Investigational Site — Newport Beach, California, United States (Recruiting)
- Vanda Investigational Site — Andover, Massachusetts, United States (Not_yet_recruiting)
- Vanda Investigational Site — Shelby, North Carolina, United States (Not_yet_recruiting)
- Vanda Investigational Site — Memphis, Tennessee, United States (Recruiting)
- Vanda Investigational Site — Lynchburg, Virginia, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.