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The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUFA (polyunsaturated fatty acids)-group | Other | REMOGEN OMEGA: Usage according to instructions for use. |
|
| C (control)-group | Other | Povidone: Usage according to instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMOGEN OMEGA | Device | Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI©) questionnaire | Week 4 | |
| Tear film stability | Tear film breakup time (unit: seconds) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI questionnaire | Day 0, Week 12 | |
| Tear film stability | Tear film breakup time (unit: seconds) | Day 0, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Kaercher, Dr. | Praxis Dr. Thomas Kaercher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Kaercher | Heidelberg | Baden-Wurttemberg | 69121 | Germany | ||
| Praxis Prof. Dr. Anselm Kampik & Kollegen |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Povidone | Device | Artificial tears: preservative-free eye drops containing 2% povidone. |
|
| Visual acuity (best corrected) |
| Day 0, Week 4, Week 12 |
| TearLab osmolarity test | Day 0, Week 4, Week 12 |
| Inflammation marker matrix metalloproteinase 9 (MMP9) | Day 0, Week 4, Week 12 |
| Lid-parallel conjunctival fold (LIPCOF) grading | Day 0, Week 4, Week 12 |
| Corneal staining | Oxford grading scale | Day 0, Week 4, Week 12 |
| Tear volume | Schirmer test | Day 0, Week 4, Week 12 |
| Conjunctival staining | Oxford grading scale | Day 0, Week 4, Week 12 |
| Munich |
| Bavaria |
| 80333 |
| Germany |
| Augenzentrum Olching | Olching | Bavaria | 82140 | Germany |
| Augenheilkunde Lindenthal | Köln-Lindenthal | North Rhine-Westphalia | 50931 | Germany |
| Dr. Flamm & Böker: Augenärzte am Tibarg | Hamburg | 22459 | Germany |