Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Conditions
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Myopia, Astigmatism

Intervention / Treatment
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* Device: Lotrafilcon B contact lenses
* Device: Comfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air Optix<br>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<br>* Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription<br>* Other names: AIR OPTIX® for ASTIGMATISM;|
| Active Comparator: Biofinity<br>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<br>* Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription<br>* Other names: Biofinity® Toric;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, myopia, astigmatism