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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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, weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

ABBV-444

Topical eye drop

DRUG

REFRESH OPTIVE UD

Topical eye drop

Locations (20)

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