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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.
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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 four times a day and an additional four times a day on an as needed basis. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slade & Baker Vision | Houston | Texas | 77027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35585427 | Result | Cavanagh B, Gomes PJ, Starr CE, Nichols KK, Brady TC. Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial. Ophthalmol Ther. 2022 Aug;11(4):1449-1461. doi: 10.1007/s40123-022-00520-z. Epub 2022 May 18. |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks |
| FG001 | Reproxalap Ophthalmic Solution (0.5%) |
| 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 | Aug 24, 2018 | Mar 1, 2023 |
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| Reproxalap Ophthalmic Solution (0.5%) | Drug | Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis. |
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| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis. |
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Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks
| FG002 | Vehicle Ophthalmic Solution | Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks |
| BG001 | Reproxalap Ophthalmic Solution (0.5%) | Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks |
| BG002 | Vehicle Ophthalmic Solution | Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks |
| 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/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | 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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| 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 | 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. | Intent-to-treat population and subjects with pollen count greater than 325 grains per cubic meter. | Posted | Least Squares Mean | Standard Error | units on a scale | Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week 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 five weeks.
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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 four times daily, plus up to four more doses daily as needed, for 4 weeks | 0 | 18 | 0 | 18 | 14 | 18 |
| EG001 | Reproxalap Ophthalmic Solution (0.5%) | Reproxalap administered four times daily, plus up to four more doses daily as needed, for 4 weeks | 0 | 17 | 1 | 17 | 16 | 17 |
| EG002 | Vehicle Ophthalmic Solution | Vehicle administered four times daily, plus up to four more doses daily as needed, for 4 weeks | 0 | 17 | 0 | 17 | 3 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Central nervous system lesion | Nervous system disorders | MedDRA 25.1 | Systematic Assessment | The non-ocular serious adverse event was deemed not related to study drug by the Principal Investigator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Conjunctival disorder | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Eye Swelling | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 25.1 | Systematic Assessment |
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| Vitreous floaters | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Instillation site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
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| 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 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 | Jan 23, 2019 | Mar 1, 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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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Unknown |
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| Not Reported |
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| Other |
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| Multiple |
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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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