A Phase 1/2 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 52 is below 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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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: Reproxalap Ophthalmic Solution (0.5%)
Drug: Vehicle Ophthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.
Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.
Change From Baseline Ocular Itching Score on High Pollen Days
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.
Time frame: Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.
| Milestone | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| Started | 18 | 17 | 17 |
| Completed | 17 | 15 | 17 |
| Not completed | 1 | 2 | 0 |
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.
| units on a scale | Reproxalap Ophthalmic Solution (0.25%) | Vehicle Ophthalmic Solution | Reproxalap Ophthalmic Solution (0.5%) |
|---|---|---|---|
| Change From Baseline Ocular Itching Score on High Pollen Days | -0.65 ± 0.17 | 0.16 ± 0.18 | -0.69 ± 0.30 |
Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | 0/18 (0%) | 0/18 (0%) | 14/18 (77.8%) |
| Reproxalap Ophthalmic Solution (0.5%) | 0/17 (0%) | 1/17 (5.9%) | 16/17 (94.1%) |
| Vehicle Ophthalmic Solution | 0/17 (0%) | 0/17 (0%) | 3/17 (17.6%) |
| Event | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| Central nervous system lesionNervous system disorders | 0/18 | 1/17 | 0/17 |
| Event | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 13/18 | 16/17 | 0/17 |
| Skin test positiveInvestigations | 1/18 | 0/17 | 1/17 |
| HeadacheNervous system disorders | 0/18 | 1/17 | 0/17 |
| HypersensitivityImmune system disorders | 0/18 | 1/17 | 0/17 |
| HordeolumInfections and infestations | 0/18 | 0/17 | 1/17 |
| Conjunctival disorderEye disorders | 1/18 | 1/17 | 0/17 |
| BlepharitisEye disorders | 0/18 | 1/17 | 0/17 |
| Dry eyeEye disorders | 0/18 | 1/17 | 0/17 |
| Eye dischargeEye disorders | 0/18 | 1/17 | 0/17 |
| Eye SwellingEye disorders | 0/18 | 0/17 | 1/17 |
| Age, Categorical(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 16 | 16 | 48 |
| >=65 years | 2 | 1 | 1 | 4 |
| Sex: Female, Male(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Female | 13 | 11 | 11 | 35 |
| Male | 5 | 6 | 6 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 9 | 11 | 30 |
| Not Hispanic or Latino | 8 | 8 | 6 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Black or African American | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| White | 15 | 17 | 16 | 48 |
| Unknown | 0 | 0 | 0 | 0 |
| Not Reported | 0 | 0 | 0 | 0 |
| Other | 1 | 0 | 0 | 1 |
| Multiple | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| United States | 18 | 17 | 17 | 52 |
| Iris Color (Right Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Black | 1 | 0 | 1 | 2 |
| Blue | 3 | 3 | 2 | 8 |
| Brown | 10 | 10 | 13 | 33 |
| Hazel | 1 | 2 | 1 | 4 |
| Green | 3 | 2 | 0 | 5 |
| Gray | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 0 |
| Iris Color (Left Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Black | 1 | 0 | 1 | 2 |
| Blue | 3 | 3 | 2 | 8 |
| Brown | 10 | 10 | 13 | 33 |
| Hazel | 1 | 2 | 1 | 4 |
| Green | 3 | 2 | 0 | 5 |
| Gray | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Nov 2019, 14 months.
Results were first posted in Apr 2025, 5 years 4 months after primary completion. A results delay was requested in Dec 2020.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Reproxalap