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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement.

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
AbbVie

526 total trials

What NCT07284381 shows while recruiting

NCT07284381 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 247-participant average among 33 other Dry Eye Disease trials with a reported enrollment target.

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Dry Eye Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07284381's enrollment target sits among peer trials

250 12th of 33 higher than 22 of 33 other Dry Eye Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07284381

Source: ClinicalTrials.gov NCT07284381, the US trial registry maintained by the National Library of Medicine. NCT07284381 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.