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| ID | Type | Description | Link |
|---|---|---|---|
| 15-MO-001 | Other Identifier | Aldeyra Therapeutics Inc. |
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This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).
Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Experimental | NS2 Ophthalmic Drops (0.5%) |
|
| NS2 Ophthalmic Drops Vehicle (0.0%) | Sham Comparator | NS2 Ophthalmic Drops Vehicle (0.0%) control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | Drug |
| ||
| NS2 Ophthalmic Drops Vehicle (0.0%) |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge | Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. | The efficacy assessment period was assessed at Day 14; baseline was Day -7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Couroux | Inflamax Research Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research Inc. | Mississauga | Ontario | L4W 1A4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | NS2 Ophthalmic Drops (0.5%) | NS2 administered QID (four times daily) for approximately 2 weeks |
| FG001 | Vehicle Ophthalmic Drops | Vehicle administered QID for approximately 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NS2 Ophthalmic Drops (0.5%) | NS2 administered QID for approximately 2 weeks |
| BG001 | Vehicle Ophthalmic Drops | Vehicle administered QID for approximately 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Score at Day 14, 60 Minutes Into the Allergen Challenge | Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | units on a scale | The efficacy assessment period was assessed at Day 14; baseline was Day -7. |
|
The period of time over which adverse events were collected for each subject was approximately 9 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 | NS2 Ophthalmic Drops (0.5%) | NS2 administered QID for approximately 2 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 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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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Vehicle administered QID for approximately 2 weeks
|
|
| 50 |
| 0 |
| 50 |
| 49 |
| 50 |
| EG001 | Vehicle Ophthalmic Drops | Vehicle administered QID for approximately 2 weeks | 0 | 50 | 0 | 50 | 11 | 50 |
|
| Lacrimination increased | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |