Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies

September 9, 2025 updated by: Vanda Pharmaceuticals

A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Allergic Conjunctivitis Using an Allergen Challenge Model

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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 Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Vanda Investigational Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years of age of either gender and any race
  • Able to provide written informed consent and sign the HIPAA form
  • Willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

  • Able and willing to avoid all disallowed medications during 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: Double

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
Ocular Itching as Measured by Self-reported Numerical Scales
Time Frame: 16 hours, 8 hours, and 15 minutes post-treatment
Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching)
16 hours, 8 hours, and 15 minutes post-treatment
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales
Time Frame: 16 hours, 8 hours, and 15 minutes post-treatment
Change from baseline in conjunctival redness evaluated by the investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more redness)
16 hours, 8 hours, and 15 minutes post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
Time Frame: 16 hours, 8 hours, and 15 minutes post-treatment
Conjunctival redness responder rates evaluated by the investigator at 7(±1), 15(±1), and 20(±1) minutes post allergen challenge. A responder is defined as meeting 1, 1.5, or 2 points reduction from baseline, or complete response in all three time points or at least two out of the three timepoints.
16 hours, 8 hours, and 15 minutes post-treatment

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)

November 21, 2020

Primary Completion (Actual)

May 22, 2021

Study Completion (Actual)

June 28, 2021

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VSJ-110-2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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