Comparison of Two Marketed Silicone Hydrogel Lenses

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Lotrafilcon B contact lenses; Device: Samfilcon A contact lenses; Device: Hydrogen peroxide solution; Device: Saline solution

• Registration Number: NCT02495948
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-13
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-08-25
• Results First Posted: 2016-10-19
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Sign informed consent document;
• Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
• Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
• Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
• History of herpetic keratitis, corneal surgery or irregular cornea;
• Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only one lens;
• Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AOA then ULTRA	Samfilcon A contact lenses	Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
AOA then ULTRA	Hydrogen peroxide solution	Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
AOA then ULTRA	Saline solution	Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
AOA then ULTRA	Lotrafilcon B contact lenses	Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
ULTRA then AOA	Lotrafilcon B contact lenses	Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
ULTRA then AOA	Saline solution	Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
ULTRA then AOA	Samfilcon A contact lenses	Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
ULTRA then AOA	Hydrogen peroxide solution	Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

Primary Outcome Measures

Name	Time	Method
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear	Day 30, each product	The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.