Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome. Eye Diseases Moderate objective and subjective dry eye symptoms as a consequence of the dry eye disease caused by Sjögren's syndrome.
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female and male patients older than 18 2. Lid parallel conjunctival folds (LIPCOF) degree 1 or higher) 3. Lissamine green staining of minimum grade 1 or higher on the Oxford Scheme grade 4. Decreased production of aqueous tear 5. Sjögren's syndrome
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Pterygium 3. Prolonged treatment with eye drops with the exception of artificial tears 4. Active allergic keratoconjunctivitis 5. Current keratitis or conjunctivitis of infectious origin 6. Surgery affecting the eye surface or eye injuries occurred within 3 months before starting the treatment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction of lid parallel conjunctival folds is measured using the slit lamp and the Höh classification at one and three months 2. Decrease of Ocular Surface Disease Index (OSDI) is measured using Ocular Surface Disease Index (OSDI) questionnaire score at one and three months 3. Tear production is measured using Schirmer's tests at three months | — |
Primary
| Measure | Time frame |
|---|---|
| Decrease of the eye surface (lissamine green) staining is measured using the Oxford scheme grade at 1 and 3 months of treatment. | — |
Countries
Hungary