Allergic ConjunctivitisPhase 2NCT04622345

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

A Phase 2 study testing VSJ-110 in people with Allergic Conjunctivitis, run by Vanda Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: VSJ-110
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2020to 28 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Able and willing to avoid all disallowed medications during washout and study period

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanda Investigational Site
Andover, Massachusetts, 01810

Other trials in United States

About this study

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

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

Conditions: Allergic Conjunctivitis
Being tested: VSJ-110, Placebo
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VSJ-110Drug
ophthalmic solution
PlaceboDrug
ophthalmic solution

Study groups in NCT04622345
Study group	Role	What they receive
VSJ-110 Solution	Experimental	Not described Receives: Drug: VSJ-110
Placebo Solution	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 16 hours, 8 hours, and 15 minutes post-treatment

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202028 Jun 2021

First posted9 Nov 2020
Study start21 Nov 2020
Primary completion22 May 2021
Study completion28 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04622345
Sponsor's protocol ID: VP-VSJ-110-2101
Status last verified: Apr 2022
First submitted: 4 Nov 2020
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
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Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
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RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04622345
Acronym / sponsor ID: VP-VSJ-110-2101
Conditions: Allergic Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 21 Nov 2020 (actual)
Primary completion: 22 May 2021 (actual)
Study completion: 28 Jun 2021 (actual)
First posted: 9 Nov 2020 (actual)
Results: Posted 11 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
VSJ-110 Solution	Experimental	Drug: VSJ-110
Placebo Solution	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Able and willing to avoid all disallowed medications during washout and study period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VSJ-110ophthalmic solution	Drug	VSJ-110 Solution
Placeboophthalmic solution	Drug	Placebo Solution

Primary outcome

Ocular Itching as Measured by Self-reported Numerical Scales
Time frame: 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
Time frame: 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)

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VSJ-110	24	22
Placebo	23	18

Primary outcome: Ocular Itching as Measured by Self-reported Numerical Scales

Time frame: 16 hours, 8 hours, and 15 minutes post-treatment. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	VSJ-110 n = 24	Placebo n = 23
16 hours (3(±1) minutes post-challenge)	-0.228 (-0.549 to 0.093)	0.010 (-0.318 to 0.337)
16 hours (5(±1) minutes post-challenge)	-0.424 (-0.731 to -0.118)	-0.035 (-0.349 to 0.278)
16 hours (7(±1) minutes post-challenge)	-0.450 (-0.711 to -0.190)	-0.182 (-0.448 to 0.084)
8 hours (3(±1) minutes post-challenge)	-0.383 (-0.762 to -0.004)	-0.402 (-0.799 to -0.006)
8 hours (5(±1) minutes post-challenge)	-0.593 (-0.984 to -0.201)	-0.569 (-0.988 to -0.149)
8 hours (7(±1) minutes post-challenge)	-0.698 (-1.073 to -0.322)	-0.772 (-1.165 to -0.379)
15 minutes (3(±1) minutes post-challenge)	0.039 (-0.272 to 0.349)	-0.007 (-0.340 to 0.326)
15 minutes (5(±1) minutes post-challenge)	-0.248 (-0.588 to 0.093)	-0.140 (-0.505 to 0.225)

Population analysed: Efficacy analysis performed on ITT and PP populations

Primary outcome: Conjunctival Redness as Measured by Investigator Assessed Numerical Scales

Time frame: 16 hours, 8 hours, and 15 minutes post-treatment. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	VSJ-110 n = 24	Placebo n = 23
16 hours (7(±1) minutes post-challenge)	-0.280 (-0.523 to -0.036)	0.075 (-0.174 to 0.323)
16 hours (15(±1) minutes post-challenge)	-0.366 (-0.572 to -0.160)	-0.108 (-0.318 to 0.103)
16 hours (20(±1) minutes post-challenge)	-0.491 (-0.713 to -0.268)	-0.151 (-0.379 to 0.076)
8 hours (7(±1) minutes post-challenge)	-0.171 (-0.354 to 0.013)	-0.075 (-0.267 to 0.117)
8 hours (15(±1) minutes post-challenge)	-0.208 (-0.359 to -0.057)	-0.201 (-0.359 to -0.043)
8 hours (20(±1) minutes post-challenge)	-0.206 (-0.343 to -0.068)	-0.203 (-0.348 to -0.059)
15 minutes (7(±1) minutes post-challenge)	0.162 (-0.011 to 0.334)	0.252 (0.066 to 0.437)
15 minutes (15(±1) minutes post-challenge)	0.039 (-0.157 to 0.236)	0.030 (-0.181 to 0.241)

Population analysed: Efficacy analysis performed on ITT and PP populations

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AE data was collected during the 4 week treatment period plus a 7 day follow up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VSJ-110 Solution	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Placebo Solution	1 of 23 (4.3%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VSJ-110 in people with Allergic Conjunctivitis, run by Vanda Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Itching as Measured by Self-reported Numerical Scales (time frame: 16 hours, 8 hours, and 15 minutes post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04622345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.