NCT07179055

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Oct 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

September 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 10, 2025

Last Update Submit

September 10, 2025

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Corneal Staining

    Corneal 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 an 8-week treatment period

Secondary Outcomes (2)

  • Schirmer's Tear Test

    Measured over an 8-week treatment period

  • Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)

    Measured over an 8-week treatment period

Study Arms (2)

VSJ-110 Solution

EXPERIMENTAL
Drug: VSJ-110

Placebo Solution

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VSJ-110DRUG

ophthalmic solution

VSJ-110 Solution
PlaceboDRUG

ophthalmic solution

Placebo Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

  • Use of any of the disallowed medications during the washout and study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Vanda Investigational Site

Newport Beach, California, 92663, United States

RECRUITING

Vanda Investigational Site

Andover, Massachusetts, 01810, United States

NOT YET RECRUITING

Vanda Investigational Site

Shelby, North Carolina, 28150, United States

NOT YET RECRUITING

Vanda Investigational Site

Memphis, Tennessee, 38119, United States

RECRUITING

Vanda Investigational Site

Lynchburg, Virginia, 24502, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Vanda Pharmaceuticals

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 17, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)