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

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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Cationorm MD sine eye drops

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Gerhard Garhöfer, Assoc.Prof.; Phone Number: +43 1 40400 2981; Email: gerhard.garhoefer@meduniwien.ac.at
• Study Contact Backup: Name: Doreen Schmiedl, PD MD; Phone Number: +43 1 40400 29880; Email: doreen.schmiedl@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Clinical Pharmacology, Medical University of Vienna
    • Contact: Gerhard Garhoefer, MD; Phone Number: 29810 +43 1 40400; Email: gerhard.garhoefer@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

10 healthy male and female volunteers 10 male and female subjects with dry eye disease 10 male and female subjects with Meibomian gland dysfunction 10 male and female subjects with blepharospasm

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 2, 2023

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Lipid based eye drops; Tearfilm lipid layer thickness
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OPHT-031116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No