Evaporative Dry Eye Disease
Conditions
Brief summary
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.
Interventions
DEVICENovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)
Eye drops
Sponsors
Novaliq GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed ICF (Informed Consent Form) and data protection form * Patient-reported history of DED in both eyes * Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1 * Have Meibomian Gland Dysfunction (MGD) at Visit 1. * Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion criteria
* Women who are pregnant, nursing or planning a pregnancy * Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies * Wear of contact lenses * Known allergy or sensitivity to the medical device or its components * Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1. * Clinical site employees or immediate family members of the same
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling | 2 months | This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%). |
Countries
Germany
Outcome results
None listed