At a glance
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Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)
In Brief
A Phase 4 clinical trial evaluating lotrafilcon A contact lenses, Renu Multiplus, and 1 other intervention for Myopia and 2 related conditions. Completed, enrolled 218 participants across 1 site.
Detailed Summary
This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night \& Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.
Study Details
Timeline
Interventions
FDA approved soft contact lenses