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

March 5, 2024 updated by: Vanda Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VSJ-110 Solution
Drug: VSJ-110
ophthalmic solution
Placebo Comparator: Placebo Solution
Drug: Placebo
ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer's Tear Test
Time Frame: Measured over a 4-week treatment period
Schirmer's Tear Test strips are used to measure ocular fluid.
Measured over a 4-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Staining
Time Frame: 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.
Measured over a 4-week treatment period
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)
Time Frame: 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).
Measured over a 4-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VSJ-110-2201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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