Dry Eye Disease (DED)
Conditions
Brief summary
The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.
Interventions
DRUGCyclosporin
This medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle.
Sponsors
Laboratoires Thea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * No patients with other ophthalmic diseases than DED * Chronic dry eye defined as longer than six months since diagnosis * OSDI score \> 22 * Conjunctival Hyperemia ≥ Grade 3 (Efron Scale) * Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician * Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician
Exclusion criteria
Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 | at week 12 versus baseline | Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness". |
Countries
Austria
Outcome results
None listed