Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Phase 1
Completed
- Conditions
- Healthy VolunteersDry Eye Syndromes
- Interventions
- Drug: AGN-232411 Vehicle
- Registration Number
- NCT02420730
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2C: AGN-232411 Dose C AGN-232411 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. Cohort 2: AGN-232411 Vehicle 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. Cohort 1: AGN-232411 Vehicle 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. Cohort 2B: AGN-232411 Dose B AGN-232411 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. Cohort 1B: AGN-232411 Dose B AGN-232411 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. Cohort 1C: AGN-232411 Dose C AGN-232411 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. Cohort 1A: AGN-232411 Dose A AGN-232411 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. Cohort 2A: AGN-232411 Dose A AGN-232411 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) Up to 56 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Montebello Medical Center, Inc.
🇺🇸Montebello, California, United States
Sall Research Center
🇺🇸Artesia, California, United States
Lugene Eye Institute
🇺🇸Glendale, California, United States