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

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT03399292

Collaborator

(none)

Enrollment

Location

76.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Cationorm MD sine eye drops

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 12, 2017

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Tear film lipid layer thickness as measured with Lipiview II [12.04.2017-30.12.2018]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerhard Garhofer, Assoc.Prof.PD MD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03399292

Other Study ID Numbers:

OPHT-031116

First Posted:

Jan 16, 2018

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gerhard Garhofer, Assoc.Prof.PD MD, Medical University of Vienna

Lipid based eye drops

Tearfilm lipid layer thickness

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Ophthalmic Solutions

Study Results

No Results Posted as of Apr 7, 2022