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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)
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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%) dosed twice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Efficacy was assessed from 0 to 212 minutes in the allergen chamber. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research Limited | Mississauga | Ontario | L4W 1V7/L4W 1N2 | Canada |
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Seventy subjects were randomized in a three-way crossover design trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
| 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 | Nov 22, 2018 | Oct 31, 2024 |
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| Reproxalap Ophthalmic Solution (0.5%) | Drug | Reproxalap Ophthalmic Solution (0.5%) dosed twice. |
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| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution dosed twice. |
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| 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. | Efficacy was assessed from 0 to 210 minutes in the allergen chamber. |
| FG001 | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
| FG002 | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap (0.25%), Then Reproxalap (0.5%), Then Vehicle | Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
| BG001 | Reproxalap (0.5%), Then Vehicle, Then Reproxalap (0.25%) | Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Vehicle) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
| BG002 | Vehicle, Then Reproxalap (0.25%), Then Reproxalap (0.5%) | Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day washout (Washout #1), then Reproxalap (0.25%) was administered once 5 minutes before and 90 minutes after allergen chamber entry, then there was a 14-day (Washout #2), then Reproxalap (0.5%) was administered once 5 minutes before and 90 minutes after allergen chamber entry. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Mean | Full Range | 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/Ethnicity, Customized | 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 | ||||||||||||||||||||||||||
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| Primary | 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Efficacy was assessed from 0 to 212 minutes in the allergen chamber. |
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| Secondary | 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Efficacy was assessed from 0 to 212 minutes in the allergen chamber. |
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| Secondary | 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | Efficacy was assessed from 0 to 210 minutes in the allergen chamber. |
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The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen 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 (0.25%) | Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry. | 0 | 67 | 0 | 67 | 49 | 67 |
| EG001 | Reproxalap (0.5%) | Reproxalap was administered once 5 minutes before and 90 minutes after allergen chamber entry. | 0 | 69 | 0 | 69 | 56 | 69 |
| EG002 | Vehicle Ophthalmic Solution | Vehicle was administered once 5 minutes before and 90 minutes after allergen chamber entry. | 0 | 67 | 0 | 67 | 5 | 67 |
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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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Operations | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2019 | Oct 31, 2024 | 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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| American Indian or Alaska Native |
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| Black or African American |
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| Native Hawaiian / Other Pacific Islander |
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| Asian |
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| Other - Mixed |
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