Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness

Recruitment & Eligibility

Inclusion Criteria

All groups

Men and women aged over 18 years
Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
Ametropy < 6 dpt
No application of eye drops or ointments in the 24 hours preceding the screening visit 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 more likely (e.g. intake of concomitant medication that could induce DED, systemic diseases 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 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 BUT between the two eyes
Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medical device used in the study
Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing or in 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 or changed dose since ≤ 4 weeks or during the study
Alcohol abuse
Contact lens wear Meibomian gland dysfunction group
Sjögren's syndrome

Study & Design

Arm && Interventions

Group	Intervention	Description
Group 3	Cationorm MD sine eye drops	10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once
Group 1	Cationorm MD sine eye drops	10 male and female healthy subjects receive Cationorm MD sine eye drops once
Group 2	Cationorm MD sine eye drops	10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once
Group 4	Cationorm MD sine eye drops	10 male and female volunteers with receive Cationorm MD sine eye drops once

Primary Outcome Measures

Name	Time	Method
Tear film lipid layer thickness as measured with Lipiview II	12.04.2017-30.12.2018

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility