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
  • Dry Eye
  • Study Drug
  • AGN-242428
  • AGN-231868
  • Lifitegrast 5% Ophthalmic Solution
  • 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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