Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear

Phase 4

Completed

• Conditions: Corneal Epithelial Permeability
• Interventions: Drug: Daily irrigation; Device: 30-day SiH CW

• Registration Number: NCT03139812
• Lead Sponsor: University of California, Berkeley

Brief 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.

Study Timeline

• Study Start: 2012-01-15
• Primary Completion: 2012-10-15
• Study Completion: 2012-10-15
• Study First Submitted: 2017-04-17
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-01
• Last Update Submitted: 2017-05-01
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
• less than 0.75 diopters (D) of astigmatism;
• free of any ocular disease or systemic disease with ocular manifestation;

Exclusion Criteria

• history of contact lens wear within the past year;
• history of ocular surgery or serious injury;
• presence of corneal scarring;
• frequent swimming, smoking, or use of medications w/ ocular side effects;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30-day SiH CW, Daily Irrigation	Daily irrigation	Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening
30-day SiH CW, Daily Irrigation	30-day SiH CW	Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening
30-day SiH CW, No Daily Irrigation	30-day SiH CW	Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution

Primary Outcome Measures

Name	Time	Method
Risk of adverse events	Post-30-day CW of SiH contact lenses	Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall
Corneal epithelial permeability (Pdc) Post-1-Day CW	Post-1-Day CW of SiH contact lenses	Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Corneal epithelial permeability (Pdc) at Baseline	Baseline	Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
Corneal epithelial permeability (Pdc) Post-30-Day CW	Post-30-Day CW of SiH contact lenses	Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW