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This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-229666 | Experimental | One drop of AGN-229666 in each eye on Days 1 and 15. |
|
| Vehicle | Placebo Comparator | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. |
|
| Olopatadine | Active Comparator | One drop of olopatadine in each eye on Days 1 and 15. |
|
| AGN-229666/Olopatadine | Other | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. |
|
| AGN-229666/Vehicle | Other | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-229666 | Drug | One drop of AGN-229666 in the eye on Days 1 and 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Score | Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged. | Days 1 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Hyperemia Score | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged. |
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Inclusion Criteria:
-Japanese patients living in Japan with a history of allergic conjunctivitis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29543548 | Background | Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-229666 | One drop of AGN-229666 in each eye on Days 1 and 15. |
| FG001 | Vehicle | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. |
| FG002 | Olopatadine | One drop of olopatadine in each eye on Days 1 and 15. |
| FG003 | AGN-229666/Olopatadine | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. |
| FG004 | AGN-229666/Vehicle | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-229666 | One drop of AGN-229666 in each eye on Days 1 and 15. |
| BG001 | Vehicle | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 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 | Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged. | Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Days 1 and 15 | Eyes | Eyes |
|
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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 | One drop of AGN-229666 in each eye on Days 1 and 15. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | 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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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Vehicle to AGN-229666 | Drug | One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15. |
|
| Olopatadine | Drug | One drop of olopatadine in the eye on Days 1 and 15. |
|
|
| Days 1 and 15 |
| Lost to Follow-up |
|
| Personal Reasons |
|
| Other Miscellaneous Reasons |
|
| BG002 | Olopatadine | One drop of olopatadine in each eye on Days 1 and 15. |
| BG003 | AGN-229666/Olopatadine | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. |
| BG004 | AGN-229666/Vehicle | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. |
| BG005 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15. |
| OG002 | Olopatadine | One drop of olopatadine in the eye on Days 1 and 15. |
|
|
| Secondary | Conjunctival Hyperemia Score | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged. | Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Days 1 and 15 | Eyes | Eyes |
|
|
|
| 0 |
| 47 |
| 4 |
| 47 |
| EG001 | Vehicle | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. | 0 | 47 | 10 | 47 |
| EG002 | Olopatadine | One drop of olopatadine in each eye on Days 1 and 15. | 0 | 49 | 6 | 49 |
| EG003 | AGN-229666/Olopatadine | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. | 0 | 48 | 3 | 48 |
| EG004 | AGN-229666/Vehicle | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. | 0 | 49 | 5 | 49 |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
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 |