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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental |
| |
| Vehicle Ophthalmic Solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Drug | Reproxalap Ophthalmic Solution (0.25%) dosed twice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 110 to 210 minutes during allergen chamber exposure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Mississauga | Ontario | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap, Then Vehicle | Subjects first received reproxalap ophthalmic solution (0.25%) twice in a single day. After a washout period of approximately two weeks, subjects then received vehicle ophthalmic solution twice in a single day. |
| FG001 | Vehicle, Then Reproxalap |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2022 | Dec 17, 2025 |
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| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution dosed twice. |
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| 12 to 212 minutes during allergen chamber exposure |
Subjects first received vehicle ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received reproxalap ophthalmic solution (0.25%) twice in a single day. |
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| NOT COMPLETED |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap, Then Vehicle | Subjects first received reproxalap ophthalmic solution (0.25%) twice in a single day. After a washout period of approximately two weeks, subjects then received vehicle ophthalmic solution twice in a single day. |
| BG001 | Vehicle, Then Reproxalap | Subjects first received vehicle ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received reproxalap ophthalmic solution (0.25%) twice in a single day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | 110 to 210 minutes during allergen chamber exposure |
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| Secondary | 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | 12 to 212 minutes during allergen chamber exposure |
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The safety assessment period was approximately 4 hours on the study day for each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reproxalap | Reproxalap ophthalmic solution (0.25%) was dosed twice in a single day. | 0 | 130 | 0 | 130 | 93 | 130 |
| EG001 | Vehicle | Vehicle ophthalmic solution was dosed twice in a single day. | 0 | 131 | 0 | 131 | 5 | 131 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2023 | Dec 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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