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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-102 Ophthalmic Drops (0.5%) | Experimental | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
|
| ADX-102 Ophthalmic Drops (0.1%) | Experimental | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
|
| Vehicle of ADX-102 Ophthalmic Drops | Placebo Comparator | Vehicle of ADX-102 Ophthalmic Drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-102 Ophthalmic Drops (0.5%) | Drug | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported. |
| Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported. |
| Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Care Centers Management | Morrow | Georgia | 30260 | United States | ||
| Silverstein Eye Centers |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADX-102 Ophthalmic Drops (0.5%) | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
| FG001 | ADX-102 Ophthalmic Drops (0.1%) | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| FG002 | Vehicle of ADX-102 Ophthalmic Drops | Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-102 Ophthalmic Drops (0.5%) | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
| BG001 | ADX-102 Ophthalmic Drops (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 | Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported. |
|
Adverse event data was captured for approximately 5 weeks for each subject during clinical trial participation.
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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 Drops (0.5%) | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
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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 19, 2016 | Nov 17, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2017 | Nov 16, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ADX-102 Ophthalmic Drops (0.1%) | Drug | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
|
| Vehicle of ADX-102 Ophthalmic Drops | Drug | Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. |
|
| Kansas City |
| Missouri |
| 64133 |
| United States |
| Apex Eye Clinical Research | Mason | Ohio | 45040 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| BG002 | Vehicle of ADX-102 Ophthalmic Drops | Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two 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 Drops (0.1%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| OG002 | Vehicle | Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. |
|
|
| Primary | Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching 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 15), Day 15 reported. |
|
|
|
| Primary | Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. | Intent to treat with observed data only. | Posted | Mean | Standard Deviation | units on a scale | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | ADX-102 Ophthalmic Drops (0.1%) | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Vehicle of ADX-102 Ophthalmic Drops | Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. | 0 | 49 | 0 | 49 | 0 | 49 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |