Back to resultsSafety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VSJ-110
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
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
Sites / Locations
- Vanda Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VSJ-110 Solution
Placebo Solution
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04622345
Brief Title
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2020 (Actual)
Primary Completion Date
May 22, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VSJ-110 Solution
Arm Type
Experimental
Arm Title
Placebo Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VSJ-110
Intervention Description
ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
ophthalmic solution
Primary Outcome Measure Information:
Title
Ocular itching and redness as measured by self reported or investigator assessed numerical scales
Description
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
Time Frame
16 hours
Secondary Outcome Measure Information:
Title
Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales
Description
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
Time Frame
16 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vanda Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
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