Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
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
1 other identifier
interventional
47
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedStudy Start
First participant enrolled
November 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedResults Posted
Study results publicly available
September 11, 2025
CompletedSeptember 11, 2025
April 1, 2022
6 months
November 4, 2020
March 19, 2024
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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)
16 hours, 8 hours, and 15 minutes post-treatment
Secondary Outcomes (1)
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales
16 hours, 8 hours, and 15 minutes post-treatment
Study Arms (2)
VSJ-110 Solution
EXPERIMENTALPlacebo Solution
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Able and willing to avoid all disallowed medications during washout and study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanda Investigational Site
Andover, Massachusetts, 01810, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vanda Pharmaceuticals
- Organization
- Vanda Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2020
First Posted
November 9, 2020
Study Start
November 21, 2020
Primary Completion
May 22, 2021
Study Completion
June 28, 2021
Last Updated
September 11, 2025
Results First Posted
September 11, 2025
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share