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 Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Tear Formulation With REFRESH OPTIVE® Unit Dose in Patients 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 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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: ABBV-444; Drug: REFRESH OPTIVE UD

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Trinity Research Group /ID# 279914
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Arizona Eye Center - West Ray Road /ID# 267993
  • California
    • Azusa, California, United States, 91702
      • Recruiting
      • Canyon City Eyecare /ID# 267948
    • Glendale, California, United States, 91204
      • Recruiting
      • Global Research Management /ID# 267980
    • Irvine, California, United States, 92604
      • Recruiting
      • Lakeside Vision Center /ID# 268544
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Eye Research Foundation /ID# 267931
  • Florida
    • Largo, Florida, United States, 33773
      • Recruiting
      • Lee Shettle Eye and Hearing /ID# 268118
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Recruiting
      • Clayton Eye Center /ID# 268097
    • Roswell, Georgia, United States, 30076
      • Recruiting
      • Coastal Research Associates - Roswell /ID# 279915
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Kannarr Eye Care /ID# 267979
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Recruiting
      • Butchertown Clinical Trials /ID# 267887
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Recruiting
      • Moyes Eye Centers /ID# 267944
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Recruiting
      • Northern New Jersey Eye Institute /ID# 267974
  • New York
    • Rochester, New York, United States, 14618
      • Recruiting
      • Rochester Ophthalmological Group - Rochester /ID# 268374
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Recruiting
      • Core Inc /ID# 267946
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Recruiting
      • Scott and Christie and Associates /ID# 268119
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • Total Eye Care - Memphis /ID# 268327
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Southern College of Optometry /ID# 267971
    • Smyrna, Tennessee, United States, 37167
      • Recruiting
      • Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Piedmont Eye Center /ID# 267929

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1).
• Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least 1 eye at both the Screening (Day -7) and Baseline (Day 1) Visits.
• Grade 1 to 4 (modified National Eye Institute [NEI] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both Screening (Day -7) and Baseline (Day 1).
• Have used an artificial tear product for dry eye disease (DED) within 6 months of Screening (Day -7) Visit.

Exclusion Criteria:

• Participant has uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the subject at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.).
• Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) Visit and/or participant anticipates contact lens wear during the study.
• Any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-444; Participant will receive ABBV-444 as needed but at least twice a day for 90 days.	Drug: ABBV-444; Topical eye drop
Active Comparator: REFRESH OPTIVE UD; Participant will receive REFRESH PLUS as needed but at least twice a day for 90 days. (Refresh Plus is the run-in medication for 7-10 days before study treatment assignment)	Drug: REFRESH OPTIVE UD; Topical eye drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Ocular Surface Disease Index (OSDI) Score	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.	Baseline to Day 90
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Baseline to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)	Corneal staining will be evaluated in each eye at all visits and will be graded 2 minutes after instillation of the fluorescein, during which time TBUT is measured. Grade staining independently approximately 3 minutes in the 5 zones of the cornea (1 through 5) as shown below based upon a 6-point scale (0, 1, 2, 3, 4, 5) for a maximum grade of 5 in each of the 5 zones (or a total maximal score of 25 for each eye).	Baseline to Day 90
Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein	The TBUT will be determined during the approximately 3 minutes wait for corneal staining using fluorescein strips moistened with saline drops applied to the treatment area. Participants will be asked to blink normally 2 to 3 times to evenly spread the fluorescein. Then, they will be asked to not blink for as long as they can. As soon as they start holding the blink, the timing with the stopwatch will begin. The stopwatch is stopped on the first occurrence of true tear break-up, not just local thinning or tear film irregularity	Baseline to Day 90

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dry Eye Disease; ABBV-444
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: M23-730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No