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A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental |
| |
| Vehicle Ophthalmic Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Drug | Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber | Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors. | The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period. |
| Schirmer Test Mean Change From Baseline | Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors. | The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Mississauga | Ontario | L4W 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36729473 | Derived | Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19. |
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Sixty-three subjects were randomized in a crossover design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap (0.25%) First, Then Vehicle | Subjects received reproxalap six times over two consecutive days, followed by a 7-day washout, then subjects received vehicle six times over two consecutive days. |
| FG001 | Vehicle First, Then Reproxalap (0.25%) | Subjects received vehicle six times over two consecutive days, followed by a 7-day washout, then subjects received reproxalap six times over two consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap (0.25%) First, Then Vehicle | Subjects received reproxalap six times over two consecutive days, followed by a 7-day washout, then subjects received vehicle six times over two consecutive days. |
| BG001 | Vehicle First, Then Reproxalap (0.25%) |
| 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 |
| 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 | Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber | Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | The efficacy assessment period was during a 90-minute dry eye chamber; baseline was pre-dose #1 for each treatment period. |
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Two days 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 (0.25%) | Subjects received reproxalap six times over two consecutive days. |
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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 | |
|---|---|---|---|---|
| Bill Cavanagh | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
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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 | Jun 13, 2022 | Oct 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2022 | Oct 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution dosed six times over two consecutive days |
|
Subjects received vehicle six times over two consecutive days, followed by a 7-day washout, then subjects received reproxalap six times over two consecutive days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Intraocular Pressure (right eye) | Mean | Standard Deviation | mmHg |
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| Intraocular Pressure (left eye) | Mean | Standard Deviation | mmHg |
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| Vehicle |
Subjects received vehicle six times over two consecutive days. |
|
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| Primary | Schirmer Test Mean Change From Baseline | Change from baseline comparison of reproxalap to vehicle for schirmer test on a millimeter line (0 = none, 35 = maximum). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | The efficacy assessment period was assessed on the first day of two consecutive dosing days for both crossover periods; baseline was pre-dose #1 for each treatment period. |
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| 0 |
| 61 |
| 0 |
| 61 |
| 56 |
| 61 |
| EG001 | Vehicle | Subjects received vehicle six times over two consecutive days. | 0 | 60 | 0 | 60 | 2 | 60 |
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