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

NCT ID: NCT06296966

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VSJ-110 Solution

Group Type EXPERIMENTAL

VSJ-110

Intervention Type DRUG

ophthalmic solution

Placebo Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ophthalmic solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VSJ-110

ophthalmic solution

Intervention Type DRUG

Placebo

ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanda Investigational Site

Andover, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vanda Pharmaceuticals Inc.

Role: CONTACT

202-734-3400

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vanda Pharmaceuticals Inc.

Role: primary

202-734-3400

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VP-VSJ-110-2201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of TOP1630 for Dry Eye Syndrome
NCT03833388 COMPLETED PHASE2/PHASE3