Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear

Study Overview
=================
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.

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

Conditions
-----------------
Corneal Epithelial Permeability

Intervention / Treatment
-----------------
* Drug: Daily irrigation
* Device: 30-day SiH CW


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 30-day SiH CW, No Daily Irrigation<br>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 | Device: 30-day SiH CW<br>* 30-day continuous wear of silicone hydrogel contact lenses<br>|
| Other: 30-day SiH CW, Daily Irrigation<br>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 | Drug: Daily irrigation<br>* 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<br>* Other names: Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX);Device: 30-day SiH CW<br>* 30-day continuous wear of silicone hydrogel contact lenses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous contact lens wear, silicone hydrogel contact lenses, irrigation, corneal epithelial permeability, contact lens-related adverse events