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NCT07284381 · ClinicalTrials.gov registry record · Phase 3

A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease

A Phase 3 study of Dry Eye Disease, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
250
Enrollment target
20
Study locations

NCT07284381 is a Phase 3 study of Dry Eye Disease that is actively recruiting participants, run by AbbVie. The registered enrollment target is 250 participants, roughly in line with the 247-participant average among 33 other Dry Eye Disease trials with a reported enrollment target. The trial reports 20 study locations across 14 states.

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The verdict

NCT07284381, a Phase 3 study of Dry Eye Disease, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
250 participants
Enrollment target
20
Study locations

Study Summary

Dry Eye Disease (DED) refers to a long-term condition that happens when there is not enough lubrication in your eyes. This can happen when your eye cannot make enough tears or if you make poor-quality tears. The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (ABBV-444) with Refresh Optive UD for 90 days in participants with Dry Eye Disease (DED. ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). Participants will be placed into 1 of 2 treatment arms. Each group receives different treatment. Adult participants diagnosed with dry eye disease will be enrolled. Around 250 participants will be enrolled in the study at approximately 20 sites across the US In this study, participants first complete a 7-day run-in period using REFRESH PLUS® eye drops. Those eligible are then randomized to receive ABBV-444 eye drops or REFRESH OPTIVE® Unit Dose eye drops. Participants in both arms will receive treatment for a 90-day treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend multiple required study visits during the study at the study site. The effect of the treatment will be checked by medical assessments and questionnaires.

Conditions Studied

Dry Eye Disease

Interventions

  • DRUG ABBV-444
  • DRUG REFRESH OPTIVE UD

Study Locations (20)

California

  • Canyon City Eyecare /ID# 267948 - Azusa
  • Global Research Management /ID# 267980 - Glendale
  • Lakeside Vision Center /ID# 268544 - Irvine
  • Eye Research Foundation /ID# 267931 - Newport Beach

Tennessee

  • Southern College of Optometry /ID# 267971 - Memphis
  • Total Eye Care - Memphis /ID# 268327 - Memphis
  • Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939 - Smyrna

Georgia

  • Clayton Eye Center /ID# 268097 - Morrow
  • Coastal Research Associates - Roswell /ID# 279915 - Roswell

Alabama

  • Trinity Research Group /ID# 279914 - Dothan

Arizona

  • Arizona Eye Center - West Ray Road /ID# 267993 - Chandler

Florida

  • Lee Shettle Eye and Hearing /ID# 268118 - Largo

Kansas

  • Kannarr Eye Care /ID# 267979 - Pittsburg

Kentucky

  • Butchertown Clinical Trials /ID# 267887 - Louisville

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2025-12-15
Est. Completion 2026-11
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07284381

The ClinicalTrials.gov registry entry for NCT07284381 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 247-participant average among 33 other Dry Eye Disease trials with a reported enrollment target. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which ABBV-444 is the first listed.

NCT07284381 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Tennessee, Georgia.

Frequently Asked Questions

What is clinical trial NCT07284381 about?

NCT07284381 is a clinical study titled "A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease". Dry Eye Disease (DED) refers to a long-term condition that happens when there is not enough lubrication in your eyes. This can happen when your eye cannot make enough tears or if you make poor-quality tears. The purpose of this study is to compare the efficacy and safety of a new artificial tear for...

What is the current status of trial NCT07284381?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2025-12-15. Estimated completion is 2026-11.

What conditions does trial NCT07284381 study?

This clinical trial studies the following conditions: Dry Eye Disease.

What interventions are being tested in trial NCT07284381?

The interventions under investigation include: ABBV-444 (DRUG), REFRESH OPTIVE UD (DRUG).

Who is sponsoring clinical trial NCT07284381?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07284381 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.