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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
60
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Change in tear film thickness
Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops
Time frame: 1 day
Change in lipid layer thickness
Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops
Time frame: 1 day
Tear Break Up Time (TBUT)
Tear Break Up Time measured at screening visit and on study day
Time frame: 2 weeks
Visual Analogue Scale (VAS)
Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Time frame: 2 weeks
Schirmer I test
Schirmer I test measured at screening visit and on study
Time frame: 2 weeks
Ocular Surface Disease Index (OSDI) score
Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Time frame: 1 day
Corneal fluorescein staining
Corneal fluorescein staining at screening visit and on study day
Time frame: 2 weeks
Visual acuity
Visual acuity assessed at screening visit and on study day
Time frame: 2 weeks
Intraocular pressure (IOP)
Intraocular pressure measured at screening visit
Time frame: 1 day
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