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NCT04622345 Clinical Trial

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

Allergic Conjunctivitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04622345
Other study ID # VP-VSJ-110-2101
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 21, 2020
Est. completion date June 28, 2021

Study information
Verified date April 2022
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date June 28, 2021
Est. primary completion date May 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• VSJ-110
ophthalmic solution
• Placebo
ophthalmic solution

Locations
Country Name City State
United States Vanda Investigational Site Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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