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NCT Number: NCT07179055

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

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VSJ-110

Drug

ophthalmic solution

Placebo

Drug

ophthalmic solution

Primary outcomes

  1. Corneal Staining

    Time frame: 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 outcomes

  1. Schirmer's Tear Test

    Time frame: Measured over an 8-week treatment period

    Schirmer tear test strips are used to measure ocular fluid.

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

    Time frame: 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).

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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