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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Eye Neovis | Experimental | 20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops |
|
| Dry Eye Vismed | Experimental | 20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops |
|
| Dry Eye Hydrabak | Experimental | 20 Patients with dry eye syndrome receiving Hydrabak Eyedrops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neovis Total Multi® Eye Drops | Device | Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Tear Break Up Time (TBUT) |
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Inclusion Criteria
Patients will be eligible for inclusion if all these criteria are respected:
Exclusion Criteria
Patients will be excluded under the following circumstances:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30325687 | Derived | Szegedi S, Scheschy U, Schmidl D, Aranha Dos Santos V, Stegmann H, Adzhemian N, Fondi K, Bata AM, Werkmeister RM, Couderc C, Schmetterer L, Garhofer G. Effect of Single Instillation of Two Hyaluronic Acid-Based Topical Lubricants on Tear Film Thickness in Patients with Dry Eye Syndrome. J Ocul Pharmacol Ther. 2018 Nov;34(9):605-611. doi: 10.1089/jop.2018.0069. Epub 2018 Oct 16. |
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| Vismed Multi® Eye Drops | Device | Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate |
|
| Hydrabak® Eye Drops | Device | Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate |
|
Tear Break Up Time measured at screening visit and on study day
| 2 weeks |
| Visual Analogue Scale (VAS) | Visual Analogue Scale about dry eye symptoms at screening visit and on study day | 2 weeks |
| Schirmer I test | Schirmer I test measured at screening visit and on study | 2 weeks |
| Ocular Surface Disease Index (OSDI) score | Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit | 1 day |
| Corneal fluorescein staining | Corneal fluorescein staining at screening visit and on study day | 2 weeks |
| Visual acuity | Visual acuity assessed at screening visit and on study day | 2 weeks |
| Intraocular pressure (IOP) | Intraocular pressure measured at screening visit | 1 day |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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