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Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovaTears® | Experimental |
| |
| Hydrabak® | Active Comparator | Unpreserved sodium chloride (0.9%) eye drops in ABAK® system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaTears® | Device | Topical eye drops for lubrication of the ocular surface |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film thickness as measured with high resolution optical coherence tomography | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid layer thickness | 4 weeks | |
| Non-invasive tear break up time | 4 weeks | |
| Dynamic Meibomian Gland Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Garhoefer, MD | Novaliq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Clinical Pharmacology | Vienna | A-1090 | Austria |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Hydrabak® |
| Device |
Eye drops |
|
| 4 weeks |
| Blink frequency | 4 weeks |
| Symptom VAS | 4 weeks |
| Corneal fluorescein staining | 4 weeks |
| Conjunctival lissamine green staining | 4 weeks |
| Schirmer I test | 4 weeks |
| Tear film break up time | 4 weeks |
| Ocular surface disease index | 4 weeks |