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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: May 22, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: VSJ-110 Solution
  • Placebo Comparator: Placebo Solution

Clinical Trial Outcome Measures

Primary Measures

  • Ocular itching and redness as measured by self reported or investigator assessed numerical scales
    • Time Frame: 16 hours
    • 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

Secondary Measures

  • Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales
    • Time Frame: 16 hours
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanda Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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