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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
NCT07284381 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-12-15 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07284381 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Tennessee, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07284381?
The interventions under investigation include: ABBV-444 (DRUG), REFRESH OPTIVE UD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07284381?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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