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NCT06296966 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
A Four-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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06296966
Other study ID # VP-VSJ-110-2201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 29, 2024
Est. completion date July 2024

Study information
Verified date March 2024
Source Vanda Pharmaceuticals
Contact Vanda Pharmaceuticals Inc.
Phone 202-734-3400
Email clinicaltrials@vandapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• VSJ-110
ophthalmic solution
• Placebo
ophthalmic solution

Locations
Country Name City State
United States Vanda Investigational Site Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Schirmer's Tear Test Schirmer's Tear Test strips are used to measure ocular fluid. Measured over a 4-week treatment period
Secondary Ocular Staining Ocular 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 a 4-week treatment period
Secondary Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS) EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort). Measured over a 4-week treatment period
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