Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT04493658
Eligibility Criteria:
Inclusion Criteria:
* Capacity to give informed consent
* Self-reported literacy
* Best corrected visual acuity at distance 20/40 in each eye
* Signed Institutional Review Board (IRB) approved consent agreeing to terms of the study
* Additional inclusion criteria for the dry eye group (both SS- and non-SS) will include a previous diagnosis of dry eye made by an eye care specialist.
* Differentiation of SS-related versus non-SS dry eye will be made according to the 2016 revised SS classification criteria.
The classification criteria are based on the weighted sum of the below 5 items:
• SS laboratory findings
* Anti-Sjogren's Antibody A (SSA) antibody positivity
* Focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2
each scoring=3
• SS clinical findings
* Abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4) in one eye
* Schirmer test ≤ 5 mm/5 min (without anesthesia) in one eye
* Unstimulated salivary flow rate ≤ 0.1 mL/min
each scoring=1
Individuals who have a total score ≥ 4 for the items above, meet the criteria for primary SS. In other words, for final classification, an individual should have at least one laboratory and one clinical finding.
Additional inclusion criteria for control subjects will include no previous history of dry eye diagnosis, and no known history of autoimmune disease, verified using a review of systems and past medical history form.
Exclusion Criteria:
* Age less than 18 years
* Known diagnoses of: Hepatitis C infection, HIV infection, Sarcoidosis, Amyloidosis, Graft Versus Host Disease (GVHD), Cicatrizing conjunctivitis (ie. from trachoma, Stevens-Johnsons Syndrome (SJS), pemphigoid, drug induced pseudo-pemphigoid, or chemical burns, other severe ocular surface diseases such as atopic keratoconjunctivitis
* Physical or mental issues, illiteracy, language problems which might possibly interfere with reading ability or other condition that would preclude successful participation in this study
* Contact lens wear within 10 days of enrollment
* Any intraocular surgery (including cataract surgery) within the last 3 months
* Any minor ocular surgery including tear duct cauterization or plugs, within the last 30 days
* Any history of corneal surgery or cosmetic lid surgery in the past 12 months
* Best corrected vision worse than 20/40
* Pregnant or nursing
* Artificial tear use within 24 hours of study visit
* History of taking or current use of topical prescription eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).
* Patients who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash-out period" as per the discretion of the investigator and patient safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, patients on these medications will be excluded.
* Any person treated with glaucoma drops in the past (more than 30 days ago) or who had glaucoma surgery (more than 12 months ago) can be included.
* Additional exclusion criteria for control subjects will include previous history of dry eye diagnosis, or history of any known autoimmune, inflammatory or rheumatologic disease including but not limited to Sjögren's syndrome, rheumatoid arthritis, Lupus, mixed connective tissue disease, scleroderma. Also the above exclusion criteria apply to control subjects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04493658
Study Brief:
Protocol Section:
NCT04493658