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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04622345

Collaborator

(none)

Enrollment

Location

Arms

7.2

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: VSJ-110 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 21, 2020

Actual Primary Completion Date :

May 22, 2021

Actual Study Completion Date :

Jun 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VSJ-110 Solution	Drug: VSJ-110 ophthalmic solution
Placebo Comparator: Placebo Solution	Drug: Placebo ophthalmic solution

Arm

Intervention/Treatment

Experimental: VSJ-110 Solution

Drug: VSJ-110

ophthalmic solution

Placebo Comparator: Placebo Solution

Drug: Placebo

ophthalmic solution

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vanda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04622345

Other Study ID Numbers:

VP-VSJ-110-2101

First Posted:

Nov 9, 2020

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Conjunctivitis

Conjunctivitis, Allergic

Study Results

No Results Posted as of Apr 27, 2022