Dry Eye Syndromes
Conditions
Brief summary
Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients. Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.
Interventions
DRUGCyclosporin
Cyclosporin eyedrops
DRUGHydrocortisone
Hydrocortisone eyedrops
Sponsors
Hospital Hietzing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of severe keratoconjunctivitis sicca defined by: * Staining of the cornea ≥ grade III according to the Oxford scale * OSDI value ≥ 12 * Age between 18 and 90 years * Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months
Exclusion criteria
* Pregnancy (excluded with a pregnancy test in patients of childbearing potential) * Children and young people up to the age of 18 * Eye surgery in the past 6 months * Simultaneous participation in another study * Regular use of eye drops, with the exception of tear substitutes * Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tearfilm breakup time | 6 months | tearfilm breakup time measured with Fluorescein |
| corneal fluorescein staining | 6 months | corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining) |
| corneal optical aberrations | 6 months | corneal optical aberrations measured with iTrace aberrometry |
Countries
Austria
Outcome results
None listed