Phase
Condition
Dry Eye Disease
Sjogren's Syndrome
Dry Eyes
Treatment
Artificial Tears
0.003% AR-15512
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Have a previous history of DED, clinician diagnosed or patient reported, within theprevious 6 months prior to the Screening visit.
Have used artificial tears for DED symptoms within 2 months prior to the Screeningvisit.
Corrected visual acuity equal to or better than logarithm Minimum angle ofreflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), asassessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyesat both the Screening and Baseline visits.
Good general and ocular health, as determined by the investigator using medicalhistory, ophthalmic examination and history.
Other protocol specified inclusion criteria may apply.
Exclusion
Key Exclusion Criteria:
History or presence of any ocular disorder or condition (other than DED) in eithereye that would, in the opinion of the investigator, interfere with theinterpretation of the study results or subject safety.
Current evidence of other significant ophthalmic disease requiring topicalmedication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease whichthe investigator believes may interfere with study findings or interpretation.
History of ocular surgery within 1 year prior to the Screening visit; history ofcorneal transplant in one or both eyes.
Use of contact lenses in either eye within 7 days prior to the Screening visit orplanned use during the study.
Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14days prior to the Screening visit or any planned use during the study.
Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.
Other protocol-specified exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Oculus Research
Garner, North Carolina 27529
United StatesSite Not Available
Wilmington Eye
Leland, North Carolina 28451
United StatesSite Not Available
CORE, Inc.
Shelby, North Carolina 28150
United StatesSite Not Available
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas 76134
United StatesSite Not Available
Butchertown Clinical Trials
Houston, Texas 77030
United StatesSite Not Available
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