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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Arizona Eye Center - West Ray Road /ID# 267993
Chandler 5289282, Arizona 5551752 85224

Canyon City Eyecare /ID# 267948
Azusa 5325423, California 5332921 91702

Global Research Management /ID# 267980
Glendale 5352423, California 5332921 91204

Lakeside Vision Center /ID# 268544
Irvine 5359777, California 5332921 92604

Eye Research Foundation /ID# 267931
Newport Beach 5376890, California 5332921 92663

Lee Shettle Eye and Hearing /ID# 268118
Largo 4161580, Florida 4155751 33773

Clayton Eye Center /ID# 268097
Morrow 4210254, Georgia 4197000 30260

Core Inc /ID# 267946
Shelby 4491180, North Carolina 4482348 28150

Scott and Christie and Associates /ID# 268119
Cranberry Township 8643098, Pennsylvania 6254927 16066

Total Eye Care - Memphis /ID# 268327
Memphis 4641239, Tennessee 4662168 38119

Piedmont Eye Center /ID# 267929
Lynchburg 4771075, Virginia 6254928 24502

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.