Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovaTears® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaTears® Eye Drops | Device | Topical eye drops for lubrication of the ocular surface |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measured by routine ophthalmological assessment | Since this is a naturalistic medical device study under EU legislation, the primary outcome is the performance of the device in the intended indication, i.e. the performance claimed by the manufacturer in the instruction for use as determined by routine ophthalmologic assessments. For NovaTears the performance claimed is lubrication of the eye surface, stabilization of the tear film and relieve of symptoms associated with dry eye. These parameters are operationalized by multiple ophthalmological assessment which are part of routine ophthalmologic examinations including tear fluid volume as determined by the Schirmer I test, stability of the tear film as determined by Tear Film Break-Up Time and relieve of symptoms as determined by subjective patient symptom severity questionnaires and objective assessments of the corneal and conjunctival epithelia. | 5 to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tolerability measured by ophthalmological assessment | 5 to 7 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with mild to moderate hyper-evaporative dry eye disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Beckert, MD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum fuer Augenheilkunde Uniklinik Koeln | Cologne | 50937 | Germany | |||
| Praxis Dr. Kaercher |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Heidelberg |
| 69121 |
| Germany |