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Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone K25 eye drops (povidone) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| ocular discomfort by using a visual analogue scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema) | ||
| adverse events |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria are defined in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| PD. Dr. G. Auffarth | Universitäts-Augenklinik, Im Neuenheimer Feld 400, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D011205 | Povidone |
| ID | Term |
|---|---|
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |