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

Primary Purpose

Refractive Error, Myopia, Hyperopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lotrafilcon B contact lenses

Senofilcon A contact lenses

OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)

Habitual Multi-Purpose Solution (MPS)

About this trial

This is an interventional supportive care trial for Refractive Error focused on measuring Refractive error, Myopia, Hyperopia, Astigmatism, Presbyopia, Contact lenses, Contact lens solution, Comfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Air Optix/OFPM

Acuvue Oasys/Habitual MPS

Arm Description

Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system

Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01809197

First Posted

March 8, 2013

Last Updated

June 25, 2014

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01809197

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Error, Myopia, Hyperopia, Astigmatism, Presbyopia

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

387 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Air Optix/OFPM

Arm Type

Experimental

Arm Description

Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system

Arm Title

Acuvue Oasys/Habitual MPS

Arm Type

Active Comparator

Arm Description

Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system

Intervention Type

Device

Intervention Name(s)

Lotrafilcon B contact lenses

Other Intervention Name(s)

AIR OPTIX® AQUA, AIR OPTIX® AQUA Multifocal, AIR OPTIX® for Astigmatism

Intervention Description

Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions

Intervention Type

Device

Intervention Name(s)

Senofilcon A contact lenses

Other Intervention Name(s)

ACUVUE® OASYS® with HYDRACLEAR® PLUS, ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS, ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS

Intervention Description

Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions

Intervention Type

Device

Intervention Name(s)

OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)

Other Intervention Name(s)

OPTI-FREE® PureMoist™

Intervention Description

Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions

Intervention Type

Device

Intervention Name(s)

Habitual Multi-Purpose Solution (MPS)

Intervention Description

Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Primary Outcome Measure Information:

Title

Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"

Description

Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

Time Frame

Day 30; after 4 hours of lens wear

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessie Lemp, PhD

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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