Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers
Phase 4
Completed
- Conditions
- Healthy
- Registration Number
- NCT00135824
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Healthy subjects
- Older than 18 years
- Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment
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Exclusion Criteria
- Known hypersensitivity to any of the constituents of the medications
- Known allergic disposition (e.g. hay fever)
- Wearing of contact lenses
- Any kind of current eye disease (e.g. dry eye)
Additional exclusion criteria are defined in the protocol
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ocular discomfort by using a visual analogue scale (VAS)
- Secondary Outcome Measures
Name Time Method slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema) adverse events
Trial Locations
- Locations (1)
Novartis Investigational Site
🇩🇪Heidelberg, Germany