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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399292
• Other study ID #: OPHT-031116
• Status: Recruiting
• Start date: April 12, 2017
• Est. completion date: September 2, 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Gerhard Garhöfer, Assoc.Prof.
• Phone: +43 1 40400 2981
• Email: gerhard.garhoefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2, 2023
• Est. primary completion date: September 2023
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cationorm MD sine eye drops
studyparticipants receive lipidbased eye drops once only in the study eye

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film lipid layer thickness as measured with Lipiview II		12.04.2017-30.12.2018