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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.