Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1A: AGN-232411 Dose A 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
AGN-232411 topical ophthalmic solution
|
Experimental: Cohort 1B: AGN-232411 Dose B 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
AGN-232411 topical ophthalmic solution
|
Experimental: Cohort 1C: AGN-232411 Dose C 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
AGN-232411 topical ophthalmic solution
|
Placebo Comparator: Cohort 1: AGN-232411 Vehicle 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
Vehicle for AGN-232411 topical ophthalmic solution.
|
Experimental: Cohort 2A: AGN-232411 Dose A 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
AGN-232411 topical ophthalmic solution
|
Experimental: Cohort 2B: AGN-232411 Dose B 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
AGN-232411 topical ophthalmic solution
|
Experimental: Cohort 2C: AGN-232411 Dose C 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
AGN-232411 topical ophthalmic solution
|
Placebo Comparator: Cohort 2: AGN-232411 Vehicle 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
Vehicle for AGN-232411 topical ophthalmic solution.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [Up to 56 days]
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sall Research Center | Artesia | California | United States | 90701 |
2 | Lugene Eye Institute | Glendale | California | United States | 91204 |
3 | Montebello Medical Center, Inc. | Montebello | California | United States | 90640 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 232411-001