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This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A: AGN-232411 Dose A | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
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| Cohort 1B: AGN-232411 Dose B | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable. |
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| Cohort 1C: AGN-232411 Dose C | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable. |
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| Cohort 1: AGN-232411 Vehicle | Placebo Comparator | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
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| Cohort 2A: AGN-232411 Dose A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-232411 | Drug | AGN-232411 topical ophthalmic solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 56 days |
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Inclusion criteria:
Stage 1
-Healthy participants.
Stage 2 -Participants with the symptoms of dry eye disease.
Exclusion criteria:
Stage 1
-Known allergies or sensitivities to study medications, fluorescein, or lissamine green
Stage 2
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Center | Artesia | California | 90701 | United States | ||
| Lugene Eye Institute |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease.
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| Cohort 2B: AGN-232411 Dose B | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable. |
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| Cohort 2C: AGN-232411 Dose C | Experimental | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable. |
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| Cohort 2: AGN-232411 Vehicle | Placebo Comparator | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
|
| AGN-232411 Vehicle | Drug | Vehicle for AGN-232411 topical ophthalmic solution. |
|
| Glendale |
| California |
| 91204 |
| United States |
| Montebello Medical Center, Inc. | Montebello | California | 90640 | United States |