Phase
Condition
Sjogren's Syndrome
Dry Eyes
Eyelid Inflammation
Treatment
Cationorm MD sine eye drops
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All groups
Men and women aged over 18 years
Normal findings in the medical history unless the investigator considers anabnormality to be clinically irrelevant
Ametropy < 6 dpt
No application of eye drops or ointments in the 24 hours preceding the screeningvisit as well as the study day Dry eye disease group
History of dry eye disease ≥ 3 months
Schirmer I test ≤ 10 mm and ≥ 2 mm or BUT ≤ 10 sec
Normal ophthalmic findings with the exception of DED Meibomian gland disease group
Dry eye disease most likely caused by MGD, no other cause identifiable which is morelikely (e.g. intake of concomitant medication that could induce DED, systemicdiseases such as systemic arthritis or diabetes), as judged by the investigator
History of dry eye disease ≥ 3 months
Normal ophthalmic findings except dry eye disease
BUT ≤ 10 seconds Blepharospasm group
Clinical diagnosis of blepharospasm
Normal ophthalmic findings with the exception of blepharospasm and dry eye
Schirmer I test > 10 mm and BUT > 10 sec
Exclusion
Exclusion Criteria:
All groups
Clinically relevant illness in the 3 weeks before the screening or study day
Ametropy ≥ 6 dpt
Pregnancy or planned pregnancy
Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUTbetween the two eyes
Known medical history of allergy, hypersensitivity or poor tolerance to anycomponents of the medical device used in the study
Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing orin the last 4 weeks
Treatment with medication known to have a detrimental effect on tear film (e.g.antidepressants, anxiolytics, neuroleptics, antihistaminic drugs, cholinergic drugs,antimuscarinic drugs, phenothiazine, beta blockers): treatment duration ≤ 4 weeks orchanged dose since ≤ 4 weeks or during the study
Alcohol abuse
Contact lens wear Meibomian gland dysfunction group
Sjögren's syndrome
Study Design
Connect with a study center
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
AustriaSite Not Available

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