Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090, Austria
NCT Number: NCT03161080
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vienna, 1090, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be eligible for inclusion if all these criteria are respected:
Exclusion criteria
Patients will be excluded under the following circumstances:
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
Time frame: 1 day
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 measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops
Time frame: 2 weeks
Tear Break Up Time measured at screening visit and on study day
Time frame: 2 weeks
Visual Analogue Scale about dry eye symptoms at screening visit and on study day
Time frame: 2 weeks
Schirmer I test measured at screening visit and on study
Time frame: 1 day
Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit
Time frame: 2 weeks
Corneal fluorescein staining at screening visit and on study day
Time frame: 2 weeks
Visual acuity assessed at screening visit and on study day
Time frame: 1 day
Intraocular pressure measured at screening visit
Medical University of Vienna
Other
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