Recruiting
Phase 2

VSJ-110

Sponsor:

Vanda Pharmaceuticals

Code:

NCT06296966

Conditions

Dry Eye

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VSJ-110

Placebo

Study Details

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.

Conditions

Dry Eye

Study ID

NCT06296966

Start date

Feb 29, 2024

Status verified date

Mar, 2024

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VSJ-110 Solution

placebo comparator: Placebo Solution

Interventions

VSJ-110

ophthalmic solution

Placebo

ophthalmic solution

Primary outcome measure

  • Schirmer's Tear Test [ Time Frame: Measured over a 4-week treatment period ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals Inc.

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Andover, Massachusetts, United States, 01810

Contacts

Vanda Pharmaceuticals Inc.

202-734-3400clinicaltrials@vandapharma.com

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2024-03-06.