Dry Eye Disease (DED)
Conditions
Brief summary
Dry eye disease (DED) is a common, multifactorial ocular surface condition with increasing worldwide prevalence. DED induces a significant burden to the patients. Inflammatory responses involving the ocular surface including the adnexa, conjunctiva and cornea are recognized as central to its pathophysiology, as supported by in vitro, non-clinical and clinical studies. Although tear substitutes remain the mainstay of initial management, in some patients this is not sufficient to control ocular surface inflammation and associated symptoms. A new medical product (Vevizye® eye drops) has been recently approved for the treatment of DED. It contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle. Topical cyclosporine is a well-established treatment for patients with moderate to severe DED who do not achieve sufficient clinical benefit from topical lubricants alone. Perfluorobutylpentane has been found to improve the bioavailability of cyclosporine and has a long residence time for up to 8 hours. In addition, because of its low surface tension facilitates quick and uniform spreading improving the tear film layer. 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 DED characterized by ocular surface inflammation.
Interventions
DRUGVevizye® Eye Drops
Vevizye® Eye Drops, Laboratoires Thea, Clermont Ferrand, France Administration scheme: 2 times daily for 12 weeks with a 12h time interval Ingredients: Cyclosporine 1mg/mL, Perfluorobutylpentane, Ethanol, anhydrous
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 * Need to add cyclosporine eye drops to tear substitutes as judged by treating physician prior to and independently of study participation
Exclusion criteria
Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dryness score assessed by a Visual Analog Scale (VAS) and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 | Week 0 - Week 12 | Dryness score assessed by a VAS score 0-100; min 0; max 100 Unit: millimeters and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 score: 0-4; min 0, max 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale | At weeks 2, 4, 8 & 12: | Changes from baseline in conjunctival hyperemia grading with photographs (Efron) scale Scale 0-4; min 0; max 4 |
| Change from baseline in dryness score (VAS) | At weeks 2, 4, 8 & 12: | Change from baseline in dryness score (VAS) Scale 0-100; min 0; max 100 unit: millimeter |
| Changes from baseline in corneal fluorescein staining according to the NEI Scale | At weeks 2, 4, 8 & 12: | Changes from baseline in corneal fluorescein staining according to the NEI Scale Scale 0-15; min 0; max 15 |
| Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0% | At weeks 2, 4, 8 & 12: | Changes from baseline in Tear Break Up Time (BUT) with Minims- Fluorescein Sodium 2,0% Unit: seconds |
| Changes from baseline in lipid layer thickness | At weeks 2, 4, 8 & 12: | Changes from baseline in lipid layer thickness unit: nanometers |
| Changes from baseline in tear film osmolarity | At weeks 2, 4, 8 & 12: | Changes from baseline in tear film osmolarity Scale \<275 - \>400; min \<275; max \>400 Unit: mOsms/L |
| Changes from baseline in Schirmer I test using Schirmer paper strips | At weeks 2, 4, 8 & 12: | Changes from baseline in Schirmer I test using Schirmer paper strips Scale 0-40; min 0; max 40 Unit: millimeter |
| Changes from baseline in conjunctival hyperemia assessment using Mc Monnies photographic scale | At weeks 2, 4, 8 & 12 | Changes from baseline in conjunctival hyperemia assessment using Mc Monnies photographic scale |
| Changes from baseline in symptoms and quality of life using the OSDI questionnaire | At weeks 2, 4, 8 & 12: | Changes from baseline in symptoms and quality of life using the OSDI questionnaire |
| Changes from baseline in symptoms within the last 48 hours | At weeks 2, 4, 8 & 12 | Changes from baseline in symptoms within the last 48 hours |
| Patient satisfaction assessed by a VAS | At week 12 | Patient satisfaction assessed by a VAS Scale 0-100; min 0; max 100 Unit: millimeter |
Countries
Austria
Outcome results
None listed