--- a +++ b/notebooks/eligibility_criteria.txt @@ -0,0 +1,24 @@ +Description +Inclusion Criteria: +Age ≥ 18 years at inclusion date +Schirmer's test ≤ 5 mm for both eyes +NIBUT ≤ 10 s for both eyes +Previous positive result of blood test for sample anti-Ro (SS-A) or anti-La (SS-B), as indicated by medical record or lab result shown by the subject. +The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments. +Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study. +Anticipated compliance with prescribed treatment and follow-up. +Exclusion Criteria: +Recently (12 months prior enrolment) undergone nasal, sinus, or ocular surgery. +Presence of an ocular or respiratory condition that could affect the study parameters such as active ocular infection/inflammation, glaucoma, diabetic retinopathy, or upper respiratory tract infection per the Investigator's judgement. +The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation. +Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation. +The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason. +Previous (within 30 days prior to enrolment) and concurrent treatment with another investigational drug/s or device/s. +Subject is pregnant or lactating or planning to get pregnant during the duration of the study. +Show less +Ages Eligible for Study +18 Years and older (Adult, Older Adult ) +Sexes Eligible for Study +All +Accepts Healthy Volunteers +No \ No newline at end of file