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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Neovis Total Multi® Eye Drops
* Device: Vismed Multi® Eye Drops
* Device: Hydrabak® Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients will be eligible for inclusion if all these criteria are respected: Age of at least 18 years Provides written informed consent prior to study-related procedures at the screening visit Is able to understand and willing to comply with the procedures and the actions asked of him/her History of dry eye syndrome for at least 3 months Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm OSDI score ≥ 23 points Normal ophthalmic findings except dry eye syndrome Exclusion Criteria Patients will be excluded under the following circumstances: Participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day Presence or history of a severe medical condition as judged by the clinical investigator Intake of parasympathomimetic or anti-psychotic drugs Wearing of contact lenses Glaucoma in the medical history Treatment with corticosteroids in the 4 weeks preceding the study Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study Ocular infection or clinically significant inflammation not related to dry eye syndrome Ocular surgery in the 3 months preceding the study Sjögren's syndrome Stevens-Johnson syndrome History of allergic conjunctivitis Pregnancy, planned pregnancy or lactating Known hypersensitivity to any component of the study medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Eye Neovis<br>20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops | Device: Neovis Total Multi® Eye Drops<br>* Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose<br>|
| Experimental: Dry Eye Vismed<br>20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops | Device: Vismed Multi® Eye Drops<br>* Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate<br>|
| Experimental: Dry Eye Hydrabak<br>20 Patients with dry eye syndrome receiving Hydrabak Eyedrops | Device: Hydrabak® Eye Drops<br>* Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |