Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
NCT ID: NCT02420730
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
77 participants
INTERVENTIONAL
2015-06-30
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
NCT02435914
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
NCT02965846
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
NCT02815293
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
NCT04030962
A Study of AG-80308 in Dry Eye Patients
NCT05372107
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411 Vehicle
Vehicle for AGN-232411 topical ophthalmic solution.
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411
AGN-232411 topical ophthalmic solution
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.
AGN-232411 Vehicle
Vehicle for AGN-232411 topical ophthalmic solution.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AGN-232411
AGN-232411 topical ophthalmic solution
AGN-232411 Vehicle
Vehicle for AGN-232411 topical ophthalmic solution.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
-Healthy participants.
Stage 2 -Participants with the symptoms of dry eye disease.
Exclusion Criteria
-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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sall Research Center
Artesia, California, United States
Lugene Eye Institute
Glendale, California, United States
Montebello Medical Center, Inc.
Montebello, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
232411-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.