Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Healthy Volunteers, Dry Eye Syndromes
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- Sall Research Center
- Lugene Eye Institute
- Montebello Medical Center, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Cohort 1A: AGN-232411 Dose A
Cohort 1B: AGN-232411 Dose B
Cohort 1C: AGN-232411 Dose C
Cohort 1: AGN-232411 Vehicle
Cohort 2A: AGN-232411 Dose A
Cohort 2B: AGN-232411 Dose B
Cohort 2C: AGN-232411 Dose C
Cohort 2: AGN-232411 Vehicle
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.
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.
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.
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.
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.
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.
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.
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.