Allergic ConjunctivitisPhase 3NCT05234554

The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

A Phase 3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Allergic Conjunctivitis, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.

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 INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber… 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?: Reproxalap Ophthalmic Solution (0.25%)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 1 siteCanada
Study dates: 21 Jan 2022to 22 Apr 2023
Phase: Phase 3
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

Be at least 18 years of age at the time of screening of either sex or any race;
Provide written informed consent;
Be willing and able to follow instructions, and can attend all required clinical trial visits.
Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Who cannot join

Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Cliantha Research
Mississauga, Ontario

Other trials in Canada

About this study

Official title: The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)

Conditions: Allergic Conjunctivitis
Being tested: Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution
Medical subject headings: Conjunctivitis, Allergic

What participants receive

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

Reproxalap Ophthalmic Solution (0.25%)Drug
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
Vehicle Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution dosed twice.

Study groups in NCT05234554
Study group	Role	What they receive
Reproxalap Ophthalmic Solution (0.25%)	Experimental	Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution	Placebo comparator	Not described Receives: Drug: Vehicle Ophthalmic Solution

What is being measured

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

Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.
Measured: 110 to 210 minutes during allergen chamber exposure

Secondary outcomes (1)

Conjunctival Redness Evaluated by the Investigator
The method of assessment was a 9-point ocular redness scale measured in half-unit increments (0 none - 4 extremely severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 212 minutes in duration with the redness assessment being collected every 10 minutes from 12 to 212 minutes. The timepoints were assessed using mixed model repeated measures.
Measured: 12 to 212 minutes during allergen chamber exposure

Timeline

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

21 Jan 202222 Apr 2023

First posted10 Feb 2022
Study start21 Jan 2022
Primary completion22 Apr 2023
Study completion22 Apr 2023

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05234554
Sponsor's protocol ID: ADX-102-AC-026
Status last verified: Apr 2026
First submitted: 1 Feb 2022
Last updated: 14 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
ClinicalTrials.gov ID: NCT05234554
Acronym / sponsor ID: ADX-102-AC-026
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 21 Jan 2022 (actual)
Primary completion: 22 Apr 2023 (actual)
Study completion: 22 Apr 2023 (actual)
First posted: 10 Feb 2022 (actual)
Results: Posted 14 May 2026

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Reproxalap Ophthalmic Solution (0.25%)	Experimental	Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution	Placebo comparator	Drug: Vehicle Ophthalmic Solution

Who may qualify

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

Key inclusion criteria (5 listed)

Be at least 18 years of age at the time of screening of either sex or any race;
Provide written informed consent;
Be willing and able to follow instructions, and can attend all required clinical trial visits.
Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).

Key exclusion criteria (5 listed)

Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

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
Reproxalap Ophthalmic Solution (0.25%)Reproxalap Ophthalmic Solution (0.25%) dosed twice.	Drug	Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution dosed twice.	Drug	Vehicle Ophthalmic Solution

Primary outcome

Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber
Time frame: 110 to 210 minutes during allergen chamber exposure
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.

1 secondary outcome

Conjunctival Redness Evaluated by the Investigator
Time frame: 12 to 212 minutes during allergen chamber exposure

Results and safety

Results posted to the registry on 14 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reproxalap, Then Vehicle	66	66
Vehicle, Then Reproxalap	65	64

Primary outcome: Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber

Time frame: 110 to 210 minutes during allergen chamber exposure. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reproxalap n = 131	Vehicle n = 131
Value	1.48 (0.07)	1.84 (0.07)

Population analysed: Intent-to-treat population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The safety assessment period was approximately 4 hours on the study day for each intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reproxalap	0 of 130 (0%)	93 of 130 (71.5%)	0 of 130
Vehicle	0 of 131 (0%)	5 of 131 (3.8%)	0 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Allergic Conjunctivitis

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
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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RecruitingObservational study
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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 3 study testing Reproxalap Ophthalmic Solution (0.25%) in people with Allergic Conjunctivitis, run by Aldeyra Therapeutics, Inc. at 1 site in Canada.

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 5 inclusion and 5 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 14 May 2026. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 May 2026). 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?

Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber (time frame: 110 to 210 minutes during allergen chamber exposure). 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 NCT05234554.

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 14 May 2026.