Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
NCT ID: NCT04403763
Last Updated: 2024-02-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2020-07-27
2022-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo Dose
Administered as single drop in one or both eyes
Vehicle
Topical eye drop
Cohort 1: AGN-241622 Dose 1 (Low Dose)
Administered as single drop in one eye
AGN-241622
Topical eye drop
Cohort 2: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in one eye
AGN-241622
Topical eye drop
Cohort 3: AGN-241622 Dose 3 (High Dose)
Administered as single drop in one eye
AGN-241622
Topical eye drop
Cohort 4: AGN-241622 Dose 1 (Low Dose)
Administered as a single drop in each eye
AGN-241622
Topical eye drop
Cohort 5: AGN-241622 Dose 2 (Medium Dose)
Administered as single drop in each eye
AGN-241622
Topical eye drop
Cohort 6: AGN-241622 Dose 3 (High Dose)
Administered as single drop in each eye
AGN-241622
Topical eye drop
Interventions
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AGN-241622
Topical eye drop
Vehicle
Topical eye drop
Eligibility Criteria
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Inclusion Criteria
* Be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year.
* Be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor.
Exclusion Criteria
* Enrollment in another investigational drug or device study within 30 days of study participation.
* Women who are pregnant, nursing, or planning a pregnancy during the study.
40 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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United Medical Research Institute /ID# 234612
Inglewood, California, United States
Global Research Foundation /ID# 237353
Los Angeles, California, United States
North Valley Eye Medical Group, Inc. /ID# 236686
Mission Hills, California, United States
The Eye Research Foundation /ID# 234526
Newport Beach, California, United States
Quantum Clinical Trials /ID# 237330
Miami Beach, Florida, United States
Kannarr Eye Care /ID# 236718
Pittsburg, Kansas, United States
The Eye Care Institute /ID# 234507
Louisville, Kentucky, United States
Total Eye Care, PA /ID# 234454
Memphis, Tennessee, United States
PPD Clinical Research Unit - Austin /ID# 237644
Austin, Texas, United States
Eye associates /ID# 236502
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance
Other Identifiers
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2011-101-013
Identifier Type: -
Identifier Source: org_study_id
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