A Multicenter, Vehicle-controlled, Double-Masked, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Unknown Phase 1,Phase 2 NCT04030962
Study Description
This was a 2-stage study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor's determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage 2 also evaluated the safety and tolerability of AGN-242428 and AGN-231868, how effective they are in treating dry eye disease (DED), and assessed the plasma and tear exposure of both ophthalmic solutions.
Study Details
- Registry ID:
- NCT04030962
- Conditions:
- Dry Eye Disease, Dry Eye Syndrome
- Phase:
- Phase 1,Phase 2
- Target Enrollment:
- 292 participants
- Start Date:
- Age Range:
- 18–999 years
- Healthy Volunteers:
- No
Study Locations (12 sites)
-
Andover Eye Associates /ID# 232689
Andover, Massachusetts, United States -
Piedmont Eye Center /ID# 232698
Lynchburg, Virginia, United States -
Vita Eye Clinic /ID# 232721
Shelby, North Carolina, United States -
Scott and Christie and Associates /ID# 232746
Cranberry Township, Pennsylvania, United States -
Advancing Vision Research /ID# 232660
Smyrna, Tennessee, United States -
The Eye Care Institute /ID# 232683
Louisville, Kentucky, United States -
Total Eye Care, PA /ID# 232657
Memphis, Tennessee, United States -
Vision Institute Central /ID# 239910
Colorado Springs, Colorado, United States -
Cornea and Cataract Consultants of Arizona /ID# 232769
Phoenix, Arizona, United States -
Duplicate_Alpine Research Organization, Inc. /ID# 240508
Clinton, Utah, United States -
Alpine Research Organization, Inc. /ID# 240508
Clinton, Utah, United States -
The Eye Research Foundation /ID# 232696
Newport Beach, California, United States
Interested in Participating?
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