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A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Experimental |
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| Vehicle of ADX-102 Ophthalmic Solution | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Drug | ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe). | The efficacy assessment period was 4 weeks; baseline was defined as Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Ophthalmology | Birmingham | Alabama | 35233 | United States | ||
| Retinal Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADX-102 Ophthalmic Solution (0.5%) | ADX-102 administered for approximately 4 weeks |
| FG001 | Vehicle Ophthalmic Solution | Vehicle administered for approximately 4 weeks |
| 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 | Jun 20, 2018 | Feb 10, 2023 |
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| Vehicle of ADX-102 Ophthalmic Solution | Drug | Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks. |
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| Phoenix |
| Arizona |
| 85014 |
| United States |
| M&M Eye Institute | Prescott | Arizona | 86301 | United States |
| Walman Eye Center | Sun City | Arizona | 85351 | United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| University of California, Irvine | Irvine | California | 92697 | United States |
| Byers Eye Institute at Stanford University | Palo Alto | California | 85014 | United States |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95819 | United States |
| Corneal Consultants of Colorado | Littleton | Colorado | 80120 | United States |
| Danbury Eye Physicians & Surgeons | Danbury | Connecticut | 06810 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 33204 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| John Hopkins | Baltimore | Maryland | 21205 | United States |
| Valley Eye Physicians & Surgeons | Ayer | Massachusetts | 01432 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Ocular Immunology & Uveitis Foundation | Waltham | Massachusetts | 02451 | United States |
| Oakland Ophthalmic Surgery | Birmingham | Michigan | 48009 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Metropolitan Eye Research and Surgery Institute | Palisades Park | New Jersey | 07650 | United States |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | United States |
| Oregon Retina, LLP | Eugene | Oregon | 97401 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Retina and Uveitis Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-102 Ophthalmic Solution (0.5%) | ADX-102 administered for approximately 4 weeks |
| BG001 | Vehicle Ophthalmic Solution | Vehicle administered for approximately 4 weeks |
| BG002 | 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, Continuous | Mean | Standard Deviation | 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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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Subjects with Bilateral Uveitis | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe). | Intent-to-treat population | Posted | Number | Subjects | The efficacy assessment period was 4 weeks; baseline was defined as Day 1. |
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| Post-Hoc | Number of Subjects With Time to Clearance of Anterior Chamber Cells in Grade 1+ or Grade 2+ Subjects With a Baseline Anterior Chamber Cell Count > 10 | Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe). | Intent-to-treat population in grade 1+ or grade 2+ subjects with a baseline anterior chamber cell count > 10 | Posted | Number | Subjects | The efficacy assessment period was 4 weeks; baseline was defined as 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 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 | ADX-102 Ophthalmic Solution (0.5%) | ADX-102 administered for approximately 4 weeks | 0 | 61 | 1 | 61 | 36 | 61 |
| EG001 | Vehicle Ophthalmic Solution | Vehicle administered for approximately 4 weeks | 0 | 62 | 2 | 62 | 31 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA Version 19.0 | Systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | Systematic Assessment | The adverse event of suicide attempt was deemed by the Principal Investigator to be no related to drug. |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | Systematic Assessment |
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| Iridocyclitis | Eye disorders | Systematic Assessment |
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| Eye inflammation | Eye disorders | Systematic Assessment |
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| Vitreous floaters | Eye disorders | Systematic Assessment |
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| 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 | Mar 13, 2019 | Jan 17, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| C000716728 | reproxalap |
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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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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Unknown |
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| Other |
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| Left Eye |
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| Both Eyes |
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