An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07179055

Enrollment

160

Registered

2025-09-17

Start date

2025-10-31

Completion date

2026-09-30

Last updated

2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

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.

Interventions

DRUGVSJ-110

ophthalmic solution

DRUGPlacebo

ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Corneal Staining	Measured over an 8-week treatment period	Corneal Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.

Secondary

Measure	Time frame	Description
Schirmer's Tear Test	Measured over an 8-week treatment period	Schirmer tear test strips are used to measure ocular fluid.
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)	Measured over an 8-week treatment period	EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort).

Countries

United States

Contacts

Primary ContactVanda Pharmaceuticals

clinicaltrials@vandapharma.com202-734-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026