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
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 and redness as measured by self reported or investigator assessed numerical scales	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 Outcome Measures

Name	Time	Method
Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales	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

Trial Locations

Locations (1)

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