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A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® (047/SI)
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices. Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
Details
| Lead sponsor | SIFI SpA |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 96 |
| Start date | Wed Jul 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Aug 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Dry Eye Syndromes
Interventions
- Eyestil Plus®
Countries
France, Spain