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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Vismed Multi® Eye Drops; Device: Hydrabak® Eye Drops; Device: Neovis Total Multi® Eye Drops

• Registration Number: NCT03161080
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Study First Submitted: 2017-03-28
• Primary Completion: 2017-05-12
• Study Completion: 2017-05-12
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Eye Vismed	Vismed Multi® Eye Drops	20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops
Dry Eye Hydrabak	Hydrabak® Eye Drops	20 Patients with dry eye syndrome receiving Hydrabak Eyedrops
Dry Eye Neovis	Neovis Total Multi® Eye Drops	20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops

Primary Outcome Measures

Name	Time	Method
Change in tear film thickness	1 day	Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI) score	1 day	Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Intraocular pressure (IOP)	1 day	Intraocular pressure measured at screening visit
Visual Analogue Scale (VAS)	2 weeks	Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Schirmer I test	2 weeks	Schirmer I test measured at screening visit and on study
Corneal fluorescein staining	2 weeks	Corneal fluorescein staining at screening visit and on study day
Change in lipid layer thickness	1 day	Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops
Tear Break Up Time (TBUT)	2 weeks	Tear Break Up Time measured at screening visit and on study day
Visual acuity	2 weeks	Visual acuity assessed at screening visit and on study day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria