Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Study Overview
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Brief Summary
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The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.

Official Title
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Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Conditions
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Myopia, Presbyopia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 35 years of age. Spectacle add of +0.50 to +2.50 diopters (inclusive). Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day. Able to be fit in both eyes with soft multifocal lenses in available powers. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within 12 weeks of enrollment in trial. Currently enrolled in any clinical trial. Astigmatism of 1.00 diopter or more. Currently wearing excluded brands of multifocal lenses, as specified by protocol. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 35 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon B / Comfilcon A<br>Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. | Device: Lotrafilcon B contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.<br>* Other names: AIR OPTIX AQUA MULTIFOCAL;Device: Comfilcon A contact lens<br>* Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.<br>* Other names: Biofinity Multifocal;|
| Other: Comfilcon A / Lotrafilcon B<br>Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. | Device: Lotrafilcon B contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.<br>* Other names: AIR OPTIX AQUA MULTIFOCAL;Device: Comfilcon A contact lens<br>* Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.<br>* Other names: Biofinity Multifocal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | 1 week | 
| Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Presbyopia