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 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: M23-730
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 20

Brief 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

Dry Eye Disease

Keywords

Dry Eye Disease; ABBV-444

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)

  Baseline to Day 90

• Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein

  Baseline to Day 90

Study Arms (2)

ABBV-444

EXPERIMENTAL

Participant will receive ABBV-444 as needed but at least twice a day for 90 days.

Drug: ABBV-444

REFRESH OPTIVE UD

ACTIVE COMPARATOR

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

Interventions

ABBV-444 DRUG

Topical eye drop

ABBV-444

REFRESH OPTIVE UD DRUG

Topical eye drop

REFRESH OPTIVE UD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Trinity Research Group /ID# 279914

Dothan, Alabama, 36301, United States

Location

Arizona Eye Center - West Ray Road /ID# 267993

Chandler, Arizona, 85224, United States

Location

Canyon City Eyecare /ID# 267948

Azusa, California, 91702, United States

Location

Global Research Management /ID# 267980

Glendale, California, 91204, United States

Location

Lakeside Vision Center /ID# 268544

Irvine, California, 92604, United States

Location

Eye Research Foundation /ID# 267931

Newport Beach, California, 92663, United States

Location

Lee Shettle Eye and Hearing /ID# 268118

Largo, Florida, 33773, United States

Location

Clayton Eye Center /ID# 268097

Morrow, Georgia, 30260, United States

Location

Coastal Research Associates - Roswell /ID# 279915

Roswell, Georgia, 30076, United States

Location

Kannarr Eye Care /ID# 267979

Pittsburg, Kansas, 66762, United States

Location

Butchertown Clinical Trials /ID# 267887

Louisville, Kentucky, 40206, United States

Location

Moyes Eye Centers /ID# 267944

Kansas City, Missouri, 64154, United States

Location

Northern New Jersey Eye Institute /ID# 267974

South Orange, New Jersey, 07079, United States

Location

Rochester Ophthalmological Group - Rochester /ID# 268374

Rochester, New York, 14618, United States

Location

Core Inc /ID# 267946

Shelby, North Carolina, 28150, United States

Location

Scott and Christie and Associates /ID# 268119

Cranberry Township, Pennsylvania, 16066, United States

Location

Southern College of Optometry /ID# 267971

Memphis, Tennessee, 38104, United States

Location

Total Eye Care - Memphis /ID# 268327

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939

Smyrna, Tennessee, 37167, United States

Location

Piedmont Eye Center /ID# 267929

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: December 15, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (20)