Last updated: April 6, 2022
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sjogren's Syndrome
Dry Eye Disease
Eyelid Inflammation
Treatment
N/AClinical Study ID
NCT03399292
OPHT-031116
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 screening visitas 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, systemic diseasessuch 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 any componentsof 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
Total Participants: 40
Study Start date:
April 12, 2017
Estimated Completion Date:
September 02, 2023
Connect with a study center
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
AustriaActive - Recruiting
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