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.
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Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No