Comparison of Two Marketed Silicone Hydrogel Lenses

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Saline solution; Device: Samfilcon A contact lenses; Device: Hydrogen peroxide solution; Device: Lotrafilcon B contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02495948

CLA560-P001

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

168 participants in 2 patient groups

AOA then ULTRA

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Hydrogen peroxide solution

Device: Samfilcon A contact lenses

Device: Saline solution

ULTRA then AOA

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lenses

Device: Hydrogen peroxide solution

Device: Samfilcon A contact lenses

Device: Saline solution