Phase
Condition
Dry Eye Disease
Treatment
ABBV-444
REFRESH OPTIVE UD
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100scale) 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 eyeat 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 areasexamined) 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 ofScreening (Day -7) Visit.
Exclusion
Exclusion Criteria:
Participant has uncontrolled severe systemic disease that, in the assessment of theinvestigator, would put safety of the subject at risk through participation, orwhich would prevent or confound protocol-specified assessments (e.g., hypertensionand diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupuserythematosus, 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 inthe investigator's opinion, may impact the participant's study participation.
Study Design
Connect with a study center
Trinity Research Group /ID# 279914
Dothan, Alabama 36301
United StatesActive - Recruiting
Trinity Research Group /ID# 279914
Dothan 4059102, Alabama 4829764 36301
United StatesSite Not Available
Arizona Eye Center - West Ray Road /ID# 267993
Chandler, Arizona 85224
United StatesActive - Recruiting
Arizona Eye Center - West Ray Road /ID# 267993
Chandler 5289282, Arizona 5551752 85224
United StatesSite Not Available
Canyon City Eyecare /ID# 267948
Azusa, California 91702
United StatesActive - Recruiting
Global Research Management /ID# 267980
Glendale, California 91204
United StatesActive - Recruiting
Lakeside Vision Center /ID# 268544
Irvine, California 92604
United StatesActive - Recruiting
Eye Research Foundation /ID# 267931
Newport Beach, California 92663
United StatesActive - Recruiting
Canyon City Eyecare /ID# 267948
Azusa 5325423, California 5332921 91702
United StatesSite Not Available
Global Research Management /ID# 267980
Glendale 5352423, California 5332921 91204
United StatesSite Not Available
Lakeside Vision Center /ID# 268544
Irvine 5359777, California 5332921 92604
United StatesSite Not Available
Eye Research Foundation /ID# 267931
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Lee Shettle Eye and Hearing /ID# 268118
Largo, Florida 33773
United StatesActive - Recruiting
Lee Shettle Eye and Hearing /ID# 268118
Largo 4161580, Florida 4155751 33773
United StatesSite Not Available
Clayton Eye Center /ID# 268097
Morrow, Georgia 30260
United StatesActive - Recruiting
Coastal Research Associates - Roswell /ID# 279915
Roswell, Georgia 30076
United StatesActive - Recruiting
Clayton Eye Center /ID# 268097
Morrow 4210254, Georgia 4197000 30260
United StatesSite Not Available
Coastal Research Associates - Roswell /ID# 279915
Roswell 4219934, Georgia 4197000 30076
United StatesSite Not Available
Kannarr Eye Care /ID# 267979
Pittsburg, Kansas 66762
United StatesActive - Recruiting
Butchertown Clinical Trials /ID# 267887
Louisville, Kentucky 40206
United StatesActive - Recruiting
Butchertown Clinical Trials /ID# 267887
Louisville 4299276, Kentucky 6254925 40206
United StatesSite Not Available
Moyes Eye Centers /ID# 267944
Kansas City, Missouri 64154
United StatesActive - Recruiting
Moyes Eye Centers /ID# 267944
Kansas City 4393217, Missouri 4398678 64154
United StatesSite Not Available
Northern New Jersey Eye Institute /ID# 267974
South Orange, New Jersey 07079
United StatesActive - Recruiting
Northern New Jersey Eye Institute /ID# 267974
South Orange 5104836, New Jersey 5101760 07079
United StatesSite Not Available
Core Inc /ID# 267946
Shelby, North Carolina 28150
United StatesActive - Recruiting
Core Inc /ID# 267946
Shelby 4491180, North Carolina 4482348 28150
United StatesSite Not Available
Scott and Christie and Associates /ID# 268119
Cranberry Township, Pennsylvania 16066
United StatesActive - Recruiting
Scott and Christie and Associates /ID# 268119
Cranberry Township 8643098, Pennsylvania 6254927 16066
United StatesSite Not Available
Southern College of Optometry /ID# 267971
Memphis, Tennessee 38104
United StatesActive - Recruiting
Total Eye Care - Memphis /ID# 268327
Memphis, Tennessee 38119
United StatesActive - Recruiting
Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939
Smyrna, Tennessee 37167
United StatesActive - Recruiting
Southern College of Optometry /ID# 267971
Memphis 4641239, Tennessee 4662168 38104
United StatesSite Not Available
Total Eye Care - Memphis /ID# 268327
Memphis 4641239, Tennessee 4662168 38119
United StatesActive - Recruiting
Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939
Smyrna 4658590, Tennessee 4662168 37167
United StatesSite Not Available
Piedmont Eye Center /ID# 267929
Lynchburg, Virginia 24502
United StatesActive - Recruiting
Piedmont Eye Center /ID# 267929
Lynchburg 4771075, Virginia 6254928 24502
United StatesSite Not Available

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