A Phase 1/2 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.5%) in Conjunctivitis, Allergic, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
An Exploratory Clinical Trial Evaluating Reproxalap Ophthalmic Solutions (0.25% and 0.5%) 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 70 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.
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.
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.
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.
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.
Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Reproxalap Ophthalmic Solution (0.5%)
Drug: Vehicle Ophthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
Reproxalap Ophthalmic Solution (0.5%) dosed twice.
Vehicle Ophthalmic Solution dosed twice.
Subject-Reported Ocular Itching Score
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Time frame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Subject-Reported Ocular Tearing Score
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Time frame: Efficacy was assessed from 0 to 212 minutes in the allergen chamber.
Investigator-Assessed Conjunctival Redness Score
Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
Time frame: Efficacy was assessed from 0 to 210 minutes in the allergen chamber.
| Milestone | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) |
|---|---|---|---|
| Started | 22 | 25 | 23 |
| Completed | 22 | 22 | 22 |
| Not completed | 0 | 3 | 1 |
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
| units on a scale | Reproxalap (0.25%) | Reproxalap (0.5%) | Vehicle |
|---|---|---|---|
| Subject-Reported Ocular Itching Score | 16.410 ± 1.6195 | 16.964 ± 1.6150 | 22.310 ± 1.6188 |
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
| units on a scale | Reproxalap (0.25%) | Reproxalap (0.5%) | Vehicle |
|---|---|---|---|
| Subject-Reported Ocular Tearing Score | 0.8777 ± 0.0615 | 0.8915 ± 0.0613 | 1.0507 ± 0.0614 |
Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
| units on a scale | Reproxalap (0.25%) | Reproxalap Ophthalmic Solution (0.5%) | Vehicle |
|---|---|---|---|
| Investigator-Assessed Conjunctival Redness Score | 0.5004 ± 0.0458 | 0.5462 ± 0.0457 | 0.6497 ± 0.0458 |
Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen weeks.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap (0.25%) | 0/67 (0%) | 0/67 (0%) | 49/67 (73.1%) |
| Reproxalap (0.5%) | 0/69 (0%) | 0/69 (0%) | 56/69 (81.2%) |
| Vehicle Ophthalmic Solution | 0/67 (0%) | 0/67 (0%) | 5/67 (7.5%) |
| Event | Reproxalap (0.25%) | Reproxalap (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 49/67 | 56/69 | 5/67 |
| Age, Customized(years) | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Total |
|---|---|---|---|---|
| Mean | 45.50 (27 to 66) | 48.84 (28 to 67) | 46.17 (30 to 68) | 46.9 (27 to 68) |
| Sex: Female, Male(Participants) | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Total |
|---|---|---|---|---|
| Female | 12 | 16 | 14 | 42 |
| Male | 10 | 9 | 9 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 5 | 9 |
| Not Hispanic or Latino | 20 | 23 | 18 | 61 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Total |
|---|---|---|---|---|
| White | 15 | 17 | 13 | 45 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 5 | 14 |
| Native Hawaiian / Other Pacific Islander | 0 | 0 | 0 | 0 |
| Asian | 1 | 3 | 5 | 9 |
| Other - Mixed | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Total |
|---|---|---|---|---|
| Canada | 22 | 25 | 23 | 70 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Reproxalap