NCT03139812

Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear

Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: University of California, Berkeley · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.

Detailed description

The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.

Conditions

• Corneal Epithelial Permeability

Interventions

Type	Name	Description
DRUG	Daily irrigation	Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens
DEVICE	30-day SiH CW	30-day continuous wear of silicone hydrogel contact lenses

Timeline

• Start date: 2012-01-15
• Primary completion: 2012-10-15
• Completion: 2012-10-15
• First posted: 2017-05-04
• Last updated: 2017-05-04