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This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-229666 | Experimental | One to two drops of AGN-229666 twice daily in each eye for 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-229666 | Drug | One to two drops of AGN-229666 twice daily in each eye for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Day 70 |
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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 | One to two drops of AGN-229666 twice daily in each eye for 10 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-229666 | One to two drops of AGN-229666 twice daily in each eye for 10 weeks. |
| 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 | Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale | Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 70 |
|
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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 to two drops of AGN-229666 twice daily in each eye for 10 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 17.0 | 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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 140 |
| 96 |
| 140 |
| Eye Pruritus | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Eye Discharge | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Instillation Site Irritation | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Ciliary Hyperaemia | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Eyelid Oedema | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Conjunctival Oedema | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 17.0 | Non-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 |