MedTrace Logo

Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome

NCT03161080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-22

No results posted yet for this study

Summary

The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several therapeutic strategies have been proposed, but still no ideal regimen has been found. Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based on optical coherence tomography (OCT) has been developed. It has been shown in previous studies that TFT correlates well with objective signs as well as with subjective symptoms of DES.

In the present study the effects of three different topical lubricants (Neovis total multi®, Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to severe DES will be investigated using this device.

Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during this study day will provide information about the corneal residency time of the three different eye drops. Patients with moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be performed before and at pre-specified time points after instillation as secondary outcome.

Other clinical measures for DES such as determination of tear film break up time (TFBUT), corneal fluorescein staining, Schirmer I test and subjective assessments will also be performed.

Conditions

  • Dry Eye Syndromes

Interventions

DEVICE

Neovis Total Multi® Eye Drops

Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose

DEVICE

Vismed Multi® Eye Drops

Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate

DEVICE

Hydrabak® Eye Drops

Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2017-05-12
Completion
2017-05-12

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161080 on ClinicalTrials.gov