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A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental |
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| Reproxalap Ophthalmic Solution (0.5%) | Experimental |
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| 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%) administered once. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported Ocular Itching Score | Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better. | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Two-point Reduction in Itching Score | The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed. | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea Consultants of Arizon | Phoenix | Arizona | 85032 | United States | ||
| Eye Site Sacramento |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap administered once 10 minutes prior to pollen exposure |
| FG001 | Reproxalap Ophthalmic Solution (0.5%) | Reproxalap administered once 10 minutes prior to pollen exposure |
| 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 | Feb 15, 2018 | Mar 2, 2023 |
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| Reproxalap Ophthalmic Solution (0.5%) | Drug | Reproxalap Ophthalmic Solution (0.5%) administered once. |
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| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution administered once. |
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| Sacramento |
| California |
| 95819 |
| United States |
| East West Eye Institute | Torrance | California | 90505 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
| R & R Research, LLC | San Antonio | Texas | 78229 | United States |
| FG002 | Vehicle Ophthalmic Solution | Vehicle administered once 10 minutes prior to pollen exposure |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap administered once 10 minutes prior to pollen exposure |
| BG001 | Reproxalap Ophthalmic Solution (0.5%) | Reproxalap administered once 10 minutes prior to pollen exposure |
| BG002 | Vehicle Ophthalmic Solution | Vehicle administered once 10 minutes prior to pollen exposure |
| BG003 | 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, Categorical | Count of Participants | Participants |
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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 | Count of Participants | Participants |
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| Iris Color (Right Eye) | Count of Participants | Participants |
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| Iris Color (Left Eye) | Count of Participants | Participants |
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| Randomization Stratum | Itching scale is 0 to 4 (0 = none, 4 = severe) | Count of Participants | 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 | Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better. | Intent-to-treat population with observed data only | Posted | Least Squares Mean | Standard Error | units on a scale*minutes | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. |
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| Secondary | Number of Subjects With Two-point Reduction in Itching Score | The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed. | Intent-to-treat population with observed data only | Posted | Count of Participants | Participants | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. |
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The period of time over which adverse events were collected for each subject in the clinical trial was approximately two months.
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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 Ophthalmic Solution (0.25%) | Reproxalap administered once 10 minutes prior to pollen exposure | 0 | 109 | 0 | 109 | 31 | 109 |
| EG001 | Reproxalap Ophthalmic Solution (0.5%) | Reproxalap administered once 10 minutes prior to pollen exposure | 0 | 100 | 0 | 100 | 41 | 100 |
| EG002 | Vehicle Ophthalmic Solution | Vehicle administered once 10 minutes prior to pollen exposure | 0 | 109 | 0 | 109 | 1 | 109 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | MedDRA 25.1 | Systematic Assessment | Transient and self-limiting instillation site irritation that resolved in all cases. All adverse events were deemed mild in severity by the Principal Investigators. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Mar 2, 2023 | 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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| Between 18 and 65 years |
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| >=65 years |
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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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| Blue |
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| Brown |
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| Hazel |
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| Green |
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| Gray |
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| Other |
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| Blue |
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| Brown |
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| Hazel |
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| Green |
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| Gray |
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| Other |
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| > 2.7 and <= 3.5 Average Baseline Itching Score |
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| > 3.5 Average Baseline Itching Score |
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