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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Refractive Error; Myopia; Hyperopia; Astigmatism; Presbyopia	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)	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	387 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Supportive Care
Official Title:	Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Study Start Date :	April 2013
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Air Optix/OFPM; 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; Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions; Other Names: AIR OPTIX® AQUA; AIR OPTIX® AQUA Multifocal; AIR OPTIX® for Astigmatism Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS); Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions; Other Name: OPTI-FREE® PureMoist™
Active Comparator: Acuvue Oasys/Habitual MPS; 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; Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions; Other Names: ACUVUE® OASYS® with HYDRACLEAR® PLUS; ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS; ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS Device: Habitual Multi-Purpose Solution (MPS); Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Outcome Measures

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Primary Outcome Measures :

1. Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:	Jessie Lemp, PhD	Alcon Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01809197 History of Changes
Other Study ID Numbers:	M-12-056
First Posted:	March 12, 2013
Results First Posted:	July 22, 2014
Last Update Posted:	July 22, 2014
Last Verified:	June 2014

Keywords provided by Alcon Research:

Refractive error; Myopia; Hyperopia; Astigmatism	Presbyopia; Contact lenses; Contact lens solution; Comfort

Additional relevant MeSH terms:

Myopia; Astigmatism; Presbyopia; Refractive Errors; Hyperopia; Eye Diseases	Pharmaceutical Solutions; Salicylic Acid; Anti-Infective Agents; Antifungal Agents; Keratolytic Agents; Dermatologic Agents