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

Study Overview
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Brief Summary
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Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse. The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects. Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed

Official Title
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Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness in Subjects With Dry Eye Disease, Meibomian Gland Dysfunction, Blepharospasm and Healthy Subjects - a Pilot Study

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cationorm MD sine eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>10 male and female healthy subjects receive Cationorm MD sine eye drops once | Drug: Cationorm MD sine eye drops<br>* studyparticipants receive lipidbased eye drops once only in the study eye<br>|
| Group 2<br>10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once | Drug: Cationorm MD sine eye drops<br>* studyparticipants receive lipidbased eye drops once only in the study eye<br>|
| Group 3<br>10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once | Drug: Cationorm MD sine eye drops<br>* studyparticipants receive lipidbased eye drops once only in the study eye<br>|
| Group 4<br>10 male and female volunteers with receive Cationorm MD sine eye drops once | Drug: Cationorm MD sine eye drops<br>* studyparticipants receive lipidbased eye drops once only in the study eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film lipid layer thickness as measured with Lipiview II |  | 12.04.2017-30.12.2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipid based eye drops, Tearfilm lipid layer thickness