NCT06296966

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

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 26, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 26, 2024

Last Update Submit

March 5, 2024

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Schirmer's Tear Test

    Schirmer's Tear Test strips are used to measure ocular fluid.

    Measured over a 4-week treatment period

Secondary Outcomes (2)

  • Ocular Staining

    Measured over a 4-week treatment period

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

    Measured over a 4-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 (1)

Vanda Investigational Site

Andover, Massachusetts, 01810, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Vanda Pharmaceuticals Inc.

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

February 26, 2024

First Posted

March 6, 2024

Study Start

February 29, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

US(1)