Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism; Myopia
• Interventions: Device: Comfilcon A contact lenses; Device: Lotrafilcon B contact lenses

• Registration Number: NCT01629693
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Study Start: 2013-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-10
• Results First Submitted: 2014-11-03
• Results First Submitted QC: 2014-11-03
• Last Update Submitted: 2014-11-03
• Results First Posted: 2014-11-06
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofinity	Comfilcon A contact lenses	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).
Air Optix	Lotrafilcon B contact lenses	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30	Baseline, 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.