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

Not Applicable

Completed

• Conditions: Refractive Error; Presbyopia; Myopia; Hyperopia; Astigmatism
• Interventions: Device: Lotrafilcon B contact lenses; Device: Senofilcon A contact lenses; Device: Habitual Multi-Purpose Solution (MPS); Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)

• Registration Number: NCT01809197
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Study Start: 2013-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-06
• Results First Submitted: 2014-06-25
• Results First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Results First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acuvue Oasys/Habitual MPS	Habitual Multi-Purpose Solution (MPS)	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Air Optix/OFPM	OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
Air Optix/OFPM	Lotrafilcon B contact lenses	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
Acuvue Oasys/Habitual MPS	Senofilcon A contact lenses	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system

Primary Outcome Measures

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