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CompletedNCT03399292Updated May 23, 2025

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

An observational study in Dry Eye Syndromes, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Dry Eye Syndromes

Keywords

  • Lipid based eye drops
  • Tearfilm lipid layer thickness
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

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

    Drug: Cationorm MD sine eye drops

  • Group 2

    10 male and female volunteers with dry eye disease receive Cationorm MD sine eye drops once

    Drug: Cationorm MD sine eye drops

  • Group 3

    10 male and female volunteers with Maibomian gland disease receive Cationorm MD sine eye drops once

    Drug: Cationorm MD sine eye drops

  • Group 4

    10 male and female volunteers with receive Cationorm MD sine eye drops once

    Drug: Cationorm MD sine eye drops

Interventions

  • DrugCationorm MD sine eye drops

    studyparticipants receive lipidbased eye drops once only in the study eye

05

What researchers measure

Primary outcomes

  1. Tear film lipid layer thickness as measured with Lipiview II

    Time frame: 12.04.2017-30.12.2018

06

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03399292
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Assoc.Prof.PD MD, Medical University of Vienna) — Principal investigator
First posted
Jan 16, 2018
Start date
Apr 12, 2017
Primary completion
Nov 26, 2024
Completion
Nov 26, 2024
Last update
May 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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