Phase
Condition
Sjogren's Syndrome
Dry Eye Disease
Eye Disorders/infections
Treatment
Saline (NaCl 0,9 %) (placebo)
TTAX03
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years old.
Provision of signed and dated informed consent form.
Baseline VAS Dryness score ≥40
Baseline Ocular Surface Disease Index (OSDI) score ≥ 13.
Baseline corneal fluorescein staining with a total score ≥ 4 but ≤13, and ≥ 2 in atleast one region, by the NEI Grading System† in the study eye.
In the opinion of the investigator, the participant can follow oral and writteninstructions.
In the opinion of the investigator, the participant can complete all studyprocedures and visits.
Exclusion
Exclusion Criteria:
Has a corneal ectatic disorder or other ocular surface disease such as limbal stemcell deficiency or a cicatricial component (e.g., symblepharon, fornixforeshortening and lid margin/lashes abnormality) caused for example by oGVHD,irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermalnecrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival gobletcells (as with vitamin A deficiency).
Has severe blepharitis or severe obvious inflammation of the lid margin.
Has severe conjunctivochalasis.
Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid.
Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) orhistory of recurrent corneal erosion
Has neuropathic corneal pain
Has a sunken globe (due to the reduction or loss of orbital fat)
Has severe DED per corneal fluorescein staining with a total score ≥ 13by the NEIGrading System in either eye.
Prior history of intolerance or adverse events using BCL.
Have had dissolvable or temporary plug(s) (including hydrogel or Lacrifill®)inserted within 6 months prior to screening.
Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days.
Has had previous ocular surgery in the study eye within the past 12 weeks.
Plans to use autologous serum drops during the study period in either eye.
Has elevated intraocular pressure >21mmHg in either eye requiring topical therapy.
Is currently using or plans to use topical glaucoma medication in either eye.
Has a known allergy to topical ophthalmic sodium fluorescein dye.
Has a known intolerance to unbuffered normal saline.
Prior adverse events of using human birth tissue product.
Is currently incarcerated or anticipates possible incarceration during the timecourse of this study.
Has tested positive for COVID-19 within 28 days prior to screening.
Is currently participating in any other type of eye-related clinical or researchstudy that in the opinion of the investigator would confound or would riskconfounding study results.
Has a condition or is in a situation which, in the investigator's opinion, may putthe participant at significant risk, may confound study outcomes, or maysignificantly interfere with the participant's participation in the study.
Prior amniotic membrane product used for dry eye therapy in the study eye in thepast 6 months.
Has Strabismus (squint/crossed eyes) or Amblyopia (lazy eye).
Study Design
Study Description
Connect with a study center
University California Berkeley
Berkeley, California 94720
United StatesSite Not Available
University California Berkeley
Berkeley 5327684, California 5332921 94720
United StatesActive - Recruiting
Advanced Research, LLC.
Deerfield Beach 4153071, Florida 4155751 33064
United StatesActive - Recruiting
Eye Health Vision Center/Claris Vision LLC
South Dartmouth, Massachusetts 02747
United StatesSite Not Available
Eye Health Vision Center/Claris Vision LLC
South Dartmouth 4951356, Massachusetts 6254926 02747
United StatesActive - Recruiting
Southwest Eye Care
Chaska, Minnesota 55318
United StatesSite Not Available
Southwest Eye Care
Chaska 5020938, Minnesota 5037779 55318
United StatesActive - Recruiting
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
United StatesActive - Recruiting
Eye Associates of North Jersey
Dover, New Jersey 07801
United StatesSite Not Available
Northern New Jersey Eye Institute
South Orange, New Jersey 07079
United StatesSite Not Available
Eye Associates of North Jersey
Dover 5097315, New Jersey 5101760 07801
United StatesActive - Recruiting
Northern New Jersey Eye Institute
South Orange 5104836, New Jersey 5101760 07079
United StatesActive - Recruiting
Wilmington Eye at Brunswick Forest
Leland, North Carolina 28451
United StatesSite Not Available
CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina 28150
United StatesSite Not Available
Wilmington Eye at Brunswick Forest
Leland 4475622, North Carolina 4482348 28451
United StatesActive - Recruiting
CORE, Inc. / Vita Eye Clinic
Shelby 4491180, North Carolina 4482348 28150
United StatesActive - Recruiting
Westlake Eye Specialists
Austin, Texas 78749
United StatesSite Not Available
Westlake Eye Specialists
Austin 4671654, Texas 4736286 78749
United StatesActive - Recruiting
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