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 but ≤ 32.
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 defined by OSDI ≥ 33 and/or presence of corneal epithelial defect orulcer in either eye.
Has severe DED per corneal fluorescein staining with a total score > 13 by theNEI Grading System† in either eye.
Prior history of intolerance or adverse events using BCL.
Have had hydrogel or other dissolvable plugs inserted within 4 weeks prior toscreening.
Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days.
Has had previous ocular surgery within the past 12 weeks.
Plans to use autologous serum drops during the study period in either eye.
Has elevated intraocular pressure 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.
Study Design
Study Description
Connect with a study center
Eye Associates of North Jersey
Dover, New Jersey 07801
United StatesActive - Recruiting
Northern New Jersey Eye Institute
South Orange, New Jersey 07079
United StatesActive - Recruiting
Wilmington Eye at Brunswick Forest
Leland, North Carolina 28451
United StatesActive - Recruiting
CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina 28150
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.