Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Study Overview
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Brief Summary
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The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.

Detailed Description
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Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Official Title
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Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Conditions
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Myopia, Refractive Error, Hyperopia, Astigmatism, Presbyopia

Intervention / Treatment
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* Device: Lotrafilcon B contact lenses
* Device: Senofilcon A contact lenses
* Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
* Device: Habitual Multi-Purpose Solution (MPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent. Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol. Willing to wear contact lenses on a daily wear basis for the duration of the study. Currently using a multi-purpose solution, as specified in protocol. Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1. Willing to follow the study procedures and visit schedule. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses. Currently using any Opti-Free brand of multi-purpose solution. Must wear contact lenses on an extended wear (overnight) basis during the study. Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products. Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear. Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1. Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1. Any abnormal ocular condition observed during the Visit 1 slit-lamp examination. Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1. Ocular surgery within the 12 months prior to Visit 1. Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions. Participation in any clinical study within 30 days of Visit 1. 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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air Optix/OFPM<br>Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system | Device: Lotrafilcon B contact lenses<br>* Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions<br>* Other names: AIR OPTIX® for Astigmatism;Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)<br>* Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions<br>* Other names: OPTI-FREE® PureMoist™;|
| Active Comparator: Acuvue Oasys/Habitual MPS<br>Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system | Device: Senofilcon A contact lenses<br>* Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions<br>* Other names: ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS;Device: Habitual Multi-Purpose Solution (MPS)<br>* Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses | Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree. | Day 30; after 4 hours of lens wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractive error, Myopia, Hyperopia, Astigmatism, Presbyopia, Contact lenses, Contact lens solution, Comfort