Dry Eye Syndromes
Conditions
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.
Interventions
DEVICENeovis Total Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
DEVICEVismed Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
DEVICEHydrabak® Eye Drops
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for inclusion if all these criteria are respected: 1. Age of at least 18 years 2. Provides written informed consent prior to study-related procedures at the screening visit 3. Is able to understand and willing to comply with the procedures and the actions asked of him/her 4. History of dry eye syndrome for at least 3 months 5. Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision 6. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm 7. OSDI score ≥ 23 points 8. Normal ophthalmic findings except dry eye syndrome
Exclusion criteria
Patients will be excluded under the following circumstances: 1. Participation in a clinical trial in the 3 weeks preceding the study 2. Symptoms of a clinically relevant illness in the 3 weeks before the first study day 3. Presence or history of a severe medical condition as judged by the clinical investigator 4. Intake of parasympathomimetic or anti-psychotic drugs 5. Wearing of contact lenses 6. Glaucoma in the medical history 7. Treatment with corticosteroids in the 4 weeks preceding the study 8. Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study 9. Ocular infection or clinically significant inflammation not related to dry eye syndrome 10. Ocular surgery in the 3 months preceding the study 11. Sjögren's syndrome 12. Stevens-Johnson syndrome 13. History of allergic conjunctivitis 14. Pregnancy, planned pregnancy or lactating 15. Known hypersensitivity to any component of the study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tear Break Up Time (TBUT) | 2 weeks | Tear Break Up Time measured at screening visit and on study day |
| 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 |
| 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 |
| Corneal fluorescein staining | 2 weeks | Corneal fluorescein staining at screening visit and on study day |
| Visual acuity | 2 weeks | Visual acuity assessed at screening visit and on study day |
| Intraocular pressure (IOP) | 1 day | Intraocular pressure measured at screening visit |
| Ocular Surface Disease Index (OSDI) score | 1 day | Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit |
Countries
Austria
Outcome results
None listed