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)
Exclusion Criteria:
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 |
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Aldeyra Therapeutics, Inc.