Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Volunteers, Dry Eye Syndromes

Intervention / Treatment
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* Drug: AGN-232411
* Drug: AGN-232411 Vehicle


Participation Criteria
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Eligibility Criteria
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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 Known allergies or sensitivities to study medications, fluorescein, or lissamine green Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months History of any ocular surgery within the previous 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1A: AGN-232411 Dose A<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Experimental: Cohort 1B: AGN-232411 Dose B<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Experimental: Cohort 1C: AGN-232411 Dose C<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Placebo Comparator: Cohort 1: AGN-232411 Vehicle<br>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. | Drug: AGN-232411 Vehicle<br>* Vehicle for AGN-232411 topical ophthalmic solution.<br>|
| Experimental: Cohort 2A: AGN-232411 Dose A<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Experimental: Cohort 2B: AGN-232411 Dose B<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Experimental: Cohort 2C: AGN-232411 Dose C<br>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. | Drug: AGN-232411<br>* AGN-232411 topical ophthalmic solution<br>|
| Placebo Comparator: Cohort 2: AGN-232411 Vehicle<br>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. | Drug: AGN-232411 Vehicle<br>* Vehicle for AGN-232411 topical ophthalmic solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) |  | Up to 56 days |