Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Lotrafilcon B contact lenses; Device: Comfilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign written informed consent document.
• Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
• Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
• Current contact lens prescription within the available parameters of both study products.
• Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
• Willing and able to follow instructions, study procedures and maintain the appointment schedule.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
• Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
• A history of ocular surgery/trauma within the last 6 months.
• Topical or systemic antibiotics use within 7 days of enrollment.
• Topical ocular or systemic corticosteroids use within 14 days of enrollment.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air Optix; Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription; Other Names: AIR OPTIX® AQUA; AIR OPTIX® for ASTIGMATISM
Active Comparator: Biofinity; Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).	Device: Comfilcon A contact lenses; Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription; Other Names: Biofinity® Sphere; Biofinity® Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30	Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.	Baseline, Day 30

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jami Kern, Ph.D., Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: astigmatism; contact lenses; myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Myopia
• Other Study ID Numbers: A00973