At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AGN-242428, AGN-231868, and 3 other interventions for Dry Eye Disease and Dry Eye Syndrome. Completed, enrolled 292 participants across 11 sites.
Detailed 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 Details
Timeline
Interventions
Ophthalmic solution administered as a topical eye drop
Ophthalmic solution administered as a topical eye drop
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Ophthalmic solution administered as a topical eye drop