A Phase 3 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Vehicle Ophthalmic Solution in Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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).
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 131 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 25 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
Vehicle Ophthalmic Solution dosed twice.
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.
Time frame: 110 to 210 minutes during allergen chamber exposure
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.
Time frame: 12 to 212 minutes during allergen chamber exposure
| Milestone | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap |
|---|---|---|
| Started | 66 | 65 |
| Completed | 66 | 64 |
| Not completed | 0 | 1 |
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.
| units on a scale | Reproxalap | Vehicle |
|---|---|---|
| Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber | 1.48 ± 0.07 | 1.84 ± 0.07 |
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.
| units on a scale | Reproxalap | Vehicle |
|---|---|---|
| Conjunctival Redness Evaluated by the Investigator | 0.69 ± 0.02 | 0.71 ± 0.02 |
Collected over The safety assessment period was approximately 4 hours on the study day for each intervention.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap | 0/130 (0%) | 0/130 (0%) | 93/130 (71.5%) |
| Vehicle | 0/131 (0%) | 0/131 (0%) | 5/131 (3.8%) |
| Event | Reproxalap | Vehicle |
|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 93/130 | 5/131 |
Intent-to-treat population
| Age, Continuous(years) | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap | Total |
|---|---|---|---|
| Mean | 40.9 ± 11.0 | 41.9 ± 12.5 | 41.4 ± 11.7 |
| Sex: Female, Male(Participants) | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap | Total |
|---|---|---|---|
| Female | 38 | 34 | 72 |
| Male | 28 | 31 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 10 | 17 |
| Not Hispanic or Latino | 59 | 55 | 114 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 11 | 10 | 21 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 11 | 17 | 28 |
| White | 37 | 34 | 71 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Reproxalap, Then Vehicle | Vehicle, Then Reproxalap | Total |
|---|---|---|---|
| Canada | 66 | 65 | 131 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2022 to primary completion in Apr 2023, 15 months.
Results were first posted in May 2026, 3 years after primary completion. A results delay was requested in Apr 2024.
Of 21 phase 3 interventional studies under Conjunctivitis, Allergic, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reproxalap