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The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Experimental |
| |
| ADX-102 Ophthalmic Solution (0.1%) | Experimental |
| |
| ADX-102 Ophthalmic Lipid Solution (0.5%) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Drug | ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale. | Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Efficacy assessment period (Day 1 through Day 29), Day 29 reported. |
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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 |
| 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 | ADX-102 Ophthalmic Solution (0.5%) | ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks. |
| FG001 | ADX-102 Ophthalmic Solution (0.1%) | ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks. |
| FG002 | ADX-102 Ophthalmic Lipid Solution (0.5%) | ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-102 Ophthalmic Solution (0.5%) | ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks. |
| BG001 | ADX-102 Ophthalmic Solution (0.1%) |
| 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 |
| 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 Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale. | Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Intent-to-treat population with observed data only. | Posted | Mean | Standard Deviation | units on a scale | Efficacy assessment period (Day 1 through Day 29), Day 29 reported. |
|
The period of time over which adverse events were collected for each subject in the clinical trial was approximately four 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 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site irritation | 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 | |
|---|---|---|---|---|
| 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 | Mar 27, 2017 | Jan 11, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2017 | Jan 11, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ADX-102 Ophthalmic Solution (0.1%) | Drug | ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks. |
|
| ADX-102 Ophthalmic Lipid Solution (0.5%) | Drug | ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. |
|
ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
| BG002 | ADX-102 Ophthalmic Lipid Solution (0.5%) | ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Iris Color (Right Eye) | Number | participants |
|
| Iris Color (Left Eye) | Number | participants |
|
ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks. |
| OG002 | ADX-102 Ophthalmic Lipid Solution (0.5%) | ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 17 |
| 17 |
| EG001 | ADX-102 Ophthalmic Solution (0.1%) | ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks. | 0 | 17 | 0 | 17 | 8 | 17 |
| EG002 | ADX-102 Ophthalmic Lipid Solution (0.5%) | ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. | 0 | 17 | 0 | 17 | 17 | 17 |
|
| Instillation site discomfort | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eyelid margin crusting | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
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