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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovaTears® + Omega-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters) | Device | Eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%). | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with evaporative Dry Eye Disease
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Kroesser, PhD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NTO-001 Investigational Site | Heidelberg | 69121 | Germany | |||
| NTO-001 Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35507946 | Derived | Jacobi C, Angstmann-Mehr S, Lange A, Kaercher T. A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study. J Ocul Pharmacol Ther. 2022 Jun;38(5):348-353. doi: 10.1089/jop.2021.0102. Epub 2022 May 4. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Nuremberg |
| 90403 |
| Germany |