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

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ClinicalTrials.gov Identifier: NCT03399292
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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
Dry Eye Syndromes Drug: Cationorm MD sine eye drops

Study Type : Observational
Estimated 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 : April 12, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. Tear film lipid layer thickness as measured with Lipiview II [ Time Frame: 12.04.2017-30.12.2018 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399292


Contacts
Contact: Gerhard Garhöfer, Assoc.Prof. +43 1 40400 2981 gerhard.garhoefer@meduniwien.ac.at
Contact: Doreen Schmiedl, PD MD +43 1 40400 29880 doreen.schmiedl@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43 1 40400 ext 29810    gerhard.garhoefer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Gerhard Garhofer, Assoc.Prof.PD MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03399292     History of Changes
Other Study ID Numbers: OPHT-031116
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gerhard Garhofer, Medical University of Vienna:
Lipid based eye drops
Tearfilm lipid layer thickness

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents