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A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the 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%) administered 7 times over two consecutive days. | Experimental |
| |
| Vehicle Ophthalmic Solution administered 7 times over two consecutive days. | 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 7 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 on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. |
| Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort, 100 = maximal discomfort), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. |
| Schirmer Test Change From Baseline After the First Dose on Day 1 | Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline and treatment group as fixed effects. | The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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One hundred fifty-eight subjects were randomized in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap (0.25%) | Reproxalap ophthalmic solution administered 7 times over two consecutive days |
| FG001 | Vehicle | Vehicle ophthalmic solution administered 7 times over two consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap (0.25%) | Reproxalap ophthalmic solution administered 7 times over two consecutive days |
| BG001 | Vehicle | Vehicle ophthalmic solution administered 7 times over two consecutive days |
| 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 on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | Intent-to-Treat Population with observed data only | Posted | Least Squares Mean | Standard Error | units on a scale | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. |
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The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.
There were 158 subjects randomized in the trial (Intent-to-treat population). There were 156 subjects exposed to study drug (Safety population). Collection of adverse events is based on the Safety population.
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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 ophthalmic solution administered 7 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 | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | 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 | Oct 12, 2021 | Feb 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2021 | Feb 2, 2023 | 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 administered 7 times over two consecutive days. |
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| BG002 | Total | Total of all reporting groups |
| 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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| OG001 | Vehicle | Vehicle ophthalmic solution administered 7 times over two consecutive days |
|
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| Primary | Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort, 100 = maximal discomfort), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | Intent-to-Treat Population with observed data only | Posted | Least Squares Mean | Standard Error | units on a scale | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. |
|
|
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| Primary | Schirmer Test Change From Baseline After the First Dose on Day 1 | Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline and treatment group as fixed effects. | Intent-to-Treat Population with observed data only | Posted | Least Squares Mean | Standard Error | length in millimeters | The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1. |
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|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 52 |
| 79 |
| EG001 | Vehicle | Vehicle ophthalmic solution administered 7 times over two consecutive days | 0 | 77 | 0 | 77 | 3 | 77 |
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