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A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental |
| |
| Reproxalap Ophthalmic Solution (0.1%) | 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%) administered for approximately twelve weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction. | Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Care Group | Waterbury | Connecticut | 06708 | United States | ||
| Midwest Cornea Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33450164 | Result | Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks. |
| FG001 | Reproxalap Ophthalmic Solution (0.1%) |
| 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 | Dec 12, 2017 | Jan 12, 2023 |
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| Reproxalap Ophthalmic Solution (0.1%) | Drug | Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. |
|
| Vehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution administered for approximately twelve weeks. |
|
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Andover Eye Associates | Raynham | Massachusetts | 02767 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
| FG002 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks. |
| BG001 | Reproxalap Ophthalmic Solution (0.1%) | Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. |
| BG002 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Iris Color (Right Eye) | Count of Participants | Participants |
| ||||||||||||||||
| Iris Color (Left Eye) | Count of Participants | 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 | Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction. | Intent to treat population with observed data only. | Posted | Least Squares Mean | Standard Error | units on a scale | Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85. |
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The period of time when adverse events were collected was approximately 3 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 Ophthalmic Solution (0.25%): Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks. | 0 | 100 | 1 | 100 | 93 | 100 |
| EG001 | Reproxalap Ophthalmic Solution (0.1%) | Reproxalap Ophthalmic Solution (0.1%): Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. | 0 | 100 | 1 | 100 | 37 | 100 |
| EG002 | Vehicle Ophthalmic Solution | Vehicle Ophthalmic Solution: Vehicle Ophthalmic Solution administered for approximately twelve weeks. | 0 | 100 | 0 | 100 | 2 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment | The serious adverse event of angina pectoris was deemed not related to study drug. |
| |
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | The serious adverse event of vertigo was deemed unlikely to be related to study drug. |
|
| 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2018 | Jan 12, 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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| 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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| Green |
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| Hazel |
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| Gray |
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| Other |
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| Blue |
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| Brown |
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| Green |
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| Hazel |
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| Gray |
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| Other |
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