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

Phase 2

Recruiting

• Conditions: Dry Eye
• Interventions: Drug: Placebo; Drug: VSJ-110

• Registration Number: NCT06296966
• Lead Sponsor: Vanda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Solution	Placebo	-
VSJ-110 Solution	VSJ-110	-

Primary Outcome Measures

Name	Time	Method
Schirmer's Tear Test	Measured over a 4-week treatment period	Schirmer's Tear Test strips are used to measure ocular fluid.

Secondary Outcome Measures

Name	Time	Method
Ocular Staining	Measured over a 4-week treatment period	Ocular Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)	Measured over a 4-week treatment period	EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Andover, Massachusetts, United States