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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: VSJ-110; Drug: Placebo

• Registration Number: NCT04622345
• Lead Sponsor: Vanda Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Study Start: 2020-11-21
• Primary Completion: 2021-05-22
• Study Completion: 2021-06-28
• Status Verified: 2022-04
• Results First Submitted: 2024-03-19
• Results First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Results First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSJ-110 Solution	VSJ-110	-
Placebo Solution	Placebo	-

Primary Outcome Measures

Name	Time	Method
Ocular Itching as Measured by Self-reported Numerical Scales	16 hours, 8 hours, and 15 minutes post-treatment	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)
Conjunctival Redness as Measured by Investigator Assessed Numerical Scales	16 hours, 8 hours, and 15 minutes post-treatment	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)

Secondary Outcome Measures

Name	Time	Method
Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales	16 hours, 8 hours, and 15 minutes post-treatment	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.

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Andover, Massachusetts, United States