NCT04030962

A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants with DED in Cohort 1A were randomized 3:3:1:1 to receive AGN-242428 (Low Dose), AGN-231868 (Low Dose), or their respective vehicles (4 treatment groups total) to the left eye on Day 1 (Visit 2). If there were no significant study drug-related safety findings, starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single dose administration to both eyes on Day 15 (Visit 5). Upon completion of Cohort 1A, an independent data monitoring committee reviewed the data before proceeding to the next cohort. Cohort 1B participants were randomized 3:3:1:1 to receive AGN-242428 (High Dose), AGN-231868 (High Dose), or their respective vehicles (4 treatment groups total) and followed the same dosing regimen used in Cohort 1A. All subjects enrolled in Stage 2 had DED. In addition, subjects were selected based on their response to a controlled adverse environment (CAE). Only subjects with DED who responded to the CAE exposure with an increase in the signs and symptoms of DED were enrolled in Stage 2. During Stage 2, participants were randomized in a 1:1:1:1:1 ratio (within each site), to receive AGN-242428 (High Dose), AGN-242428 vehicle, AGN-231868 (High Dose), AGN-231868 vehicle, or Lifitegrast Ophthalmic Solution (Xiidra). Participants administered the assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.

Conditions

• Dry Eye Disease
• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	AGN-242428	Ophthalmic solution administered as a topical eye drop
DRUG	AGN-231868	Ophthalmic solution administered as a topical eye drop
OTHER	AGN-242428 Vehicle	Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
OTHER	AGN-231868 Vehicle	Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
DRUG	Lifitegrast 5% Ophthalmic Solution	Ophthalmic solution administered as a topical eye drop

Timeline

• Start date: 2020-03-04
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2019-07-24
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study