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

Vanda Pharmaceuticals47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

VSJ-110DRUG

ophthalmic solution

PlaceboDRUG

ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanda Investigational Site

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular Itching as Measured by Self-reported Numerical Scales

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)

Time frame: 16 hours, 8 hours, and 15 minutes post-treatment

Conjunctival Redness as Measured by Investigator Assessed Numerical Scales

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)

Time frame: 16 hours, 8 hours, and 15 minutes post-treatment

Secondary Outcomes

Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales

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.

Time frame: 16 hours, 8 hours, and 15 minutes post-treatment

Data from ClinicalTrials.gov

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