NCT00937105

Daily Wear Corneal Infiltrative Event Study

Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopia
• Hyperopia
• Corneal Infiltrative Events

Interventions

Type	Name	Description
DEVICE	lotrafilcon A contact lenses	FDA approved soft contact lenses
DEVICE	Renu Multiplus
DEVICE	Clear Care

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-07-10
• Last updated: 2014-03-10
• Results posted: 2014-03-10

Locations

1 site across 1 country: United States