A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Study Identifier
2012-201-005
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 1/Phase 2
Sex
Female & Male
Age
18+ years
Protocol Summary
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 Locations
Location
Status
Location
Cornea and Cataract Consultants of Arizona /ID# 232769
Phoenix, Arizona, United States, 85032
Status
Not applicable
Location
The Eye Research Foundation /ID# 232696
Newport Beach, California, United States, 92663-3637
Status
Not applicable
Location
Vision Institute Central /ID# 239910
Colorado Springs, Colorado, United States, 80907-7529
Status
Not applicable
Location
The Eye Care Institute /ID# 232683
Louisville, Kentucky, United States, 40206
Status
Not applicable
Location
Andover Eye Associates /ID# 232689
Andover, Massachusetts, United States, 01810
Status
Not applicable
Location
Vita Eye Clinic /ID# 232721
Shelby, North Carolina, United States, 28150
Status
Not applicable
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