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

NCT04030962 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2025-05-20

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2022-03-18
Completion
2022-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030962 on ClinicalTrials.gov