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

NCT ID: NCT03399292

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2024-11-26

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

Conditions

Dry Eye Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

10 male and female healthy subjects receive Cationorm MD sine eye drops once

Cationorm MD sine eye drops

Intervention Type: DRUG

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

Cationorm MD sine eye drops

Intervention Type: DRUG

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

Cationorm MD sine eye drops

Intervention Type: DRUG

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

Cationorm MD sine eye drops

Intervention Type: DRUG

studyparticipants receive lipidbased eye drops once only in the study eye

Interventions

Cationorm MD sine eye drops

studyparticipants receive lipidbased eye drops once only in the study eye

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc.Prof.PD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

OPHT-031116

Identifier Type: -

Identifier Source: org_study_id