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This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-229666 Dose A | Experimental | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
|
| AGN-229666 Dose B | Experimental | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. |
|
| vehicle of AGN-229666 | Placebo Comparator | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-229666 | Drug | One drop of AGN-229666 into each eye on Day 1 and Day 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Score at Day 1 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Score at Day 15 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-229666 Dose A | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
| FG001 | AGN-229666 Dose B | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. |
| FG002 | Vehicle of AGN-229666 | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-229666 Dose A | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
| BG001 | AGN-229666 Dose B | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 1 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point | Posted | Mean | Standard Deviation | Score on a scale | Day 1 |
|
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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 | AGN-229666 Dose A | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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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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| vehicle of AGN-229666 | Other | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
|
| Conjunctival Hyperemia Score | Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes. | Day 1 |
| BG002 | Vehicle of AGN-229666 | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
| OG002 | Vehicle of AGN-229666 | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. |
|
|
| Secondary | Ocular Itching Score at Day 15 | The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes. | Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point | Posted | Mean | Standard Deviation | Score on a scale | Day 15 |
|
|
|
| Secondary | Conjunctival Hyperemia Score | Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes. | Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point | Posted | Mean | Standard Deviation | Score on a scale | Day 1 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | AGN-229666 Dose B | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. | 0 | 29 | 2 | 29 |
| EG002 | Vehicle of AGN-229666 | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15. | 0 | 30 | 0 | 30 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |