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

NCT ID: NCT04622345

Last Updated: 2025-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-21

Study Completion Date

2021-06-28

Brief Summary

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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

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

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VSJ-110

ophthalmic solution

Intervention Type DRUG

Placebo

ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Andover, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VP-VSJ-110-2101

Identifier Type: -

Identifier Source: org_study_id

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