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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jessie Lemp, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 8, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Hyperopia; Astigmatism; Myopia; Presbyopia; Refractive error; Comfort; Contact lenses; Contact lens solution
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism; Myopia; Hyperopia; Pharmaceutical Solutions
• Other Study ID Numbers: M-12-056