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

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: Allergic Conjunctivitis
• Intervention / Treatment: Drug: VSJ-110; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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 and redness as measured by self reported or investigator assessed numerical scales	Itching will be self-reported on a 0-4 scale, with a higher number indicating more itching; redness will be assessed by the investigator on a 0-4 scale, with a higher number indicating more redness	16 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales	Chemosis, redness and eyelid swelling will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher intensity of the measure	16 hours

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals

Study record dates

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 (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• 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