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

ClinicalTrials.gov ID: NCT04030962

Public ClinicalTrials.gov record NCT04030962. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:57 AM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04030962
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: AbbVie; Industry
Enrollment: 292 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 3, 2020
Primary completion: Mar 17, 2022
Completion: Mar 17, 2022
Last update posted: May 19, 2025

2020 – 2022

United States locations

U.S. sites: 11
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
Cornea and Cataract Consultants of Arizona /ID# 232769	Phoenix	Arizona	85032	—
The Eye Research Foundation /ID# 232696	Newport Beach	California	92663-3637	—
Vision Institute Central /ID# 239910	Colorado Springs	Colorado	80907-7529	—
The Eye Care Institute /ID# 232683	Louisville	Kentucky	40206	—
Andover Eye Associates /ID# 232689	Andover	Massachusetts	01810	—
Vita Eye Clinic /ID# 232721	Shelby	North Carolina	28150	—
Scott and Christie and Associates /ID# 232746	Cranberry Township	Pennsylvania	16066	—
Total Eye Care, PA /ID# 232657	Memphis	Tennessee	38119-5745	—
Advancing Vision Research /ID# 232660	Smyrna	Tennessee	37167	—
Duplicate_Alpine Research Organization, Inc. /ID# 240508	Clinton	Utah	84015-8562	—
Piedmont Eye Center /ID# 232698	Lynchburg	Virginia	24502	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04030962, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 19, 2025 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04030962 live on ClinicalTrials.gov.

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