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

Last updated: April 6, 2022
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eye Disease

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT03399292
OPHT-031116
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria: All groups

  • Men and women aged over 18 years
  • Normal findings in the medical history unless the investigator considers anabnormality to be clinically irrelevant
  • Ametropy < 6 dpt
  • No application of eye drops or ointments in the 24 hours preceding the screening visitas 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 morelikely (e.g. intake of concomitant medication that could induce DED, systemic diseasessuch 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

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 BUTbetween the two eyes
  • Known medical history of allergy, hypersensitivity or poor tolerance to any componentsof the medical device used in the study
  • Treatment with topical or systemic steroids, immune suppressants, NSAIDs: ongoing orin 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 orchanged dose since ≤ 4 weeks or during the study
  • Alcohol abuse
  • Contact lens wear Meibomian gland dysfunction group
  • Sjögren's syndrome

Study Design

Total Participants: 40
Study Start date:
April 12, 2017
Estimated Completion Date:
September 02, 2023

Connect with a study center

  • Department of Clinical Pharmacology, Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.