Phase
Condition
Dry Eye Disease
Sjogren's Syndrome
Eyelid Inflammation
Treatment
Eye lid procedure
Walther System
Non preserved ocular lubricants
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18
The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
History of dry eye in both or one eye, supported by a previous clinical diagnosis orhave self-reported history of complaints for at least 4 months prior to enrolment
Women of childbearing potential must agree to use a reliable, medically approvedform of contraception during the study participation until end of study
OSDI score > 15
Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
Anticipated compliance with prescribed treatment and follow-up
Exclusion
Exclusion Criteria:
Recently (3 months prior enrolment) undergone nasal or sinus surgery
Women who are pregnant as determined by urine test at inclusion and prior to studystart (applies to sites in Denmark only)
Ongoing acute upper respiratory tract infection, per the Investigator's judgement
Bleph-ex treated within 3 months prior to enrolment
The study subject has a cognitive incapacity or language barrier precluding adequateunderstanding or cooperation
The study subject is considered by the Investigator to be unsuitable to participatein the investigation for any other reason
Any severe diseases interfering with the performance, evaluation, and outcome of theclinical evaluation
Previous (within 30 days prior to enrolment/randomization) and concurrent treatmentduring the treatment phase with another investigational drug/s or device/s
Study Design
Connect with a study center
Øjenhospitalet Danmark
Charlottenlund, Copenhagen 2920
DenmarkSite Not Available
Kontaktlinse Instituttet
Århus,
DenmarkSite Not Available
Källmarkskliniken
Solna, Stockholm 171 54
SwedenSite Not Available
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