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

NCT01809197 | Completed Results

• 1 other identifier: M-12-056
• Study Type: interventional
• Target: 387
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error; Myopia; Hyperopia; Astigmatism; Presbyopia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Air Optix/OFPM

EXPERIMENTAL

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; Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)

Acuvue Oasys/Habitual MPS

ACTIVE COMPARATOR

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; Device: Habitual Multi-Purpose Solution (MPS)

Interventions

Lotrafilcon B contact lenses DEVICE

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

Also known as: AIR OPTIX® AQUA, AIR OPTIX® AQUA Multifocal, AIR OPTIX® for Astigmatism

Air Optix/OFPM

Senofilcon A contact lenses DEVICE

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

Also known as: ACUVUE® OASYS® with HYDRACLEAR® PLUS, ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS, ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS

Acuvue Oasys/Habitual MPS

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

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

Also known as: OPTI-FREE® PureMoist™

Air Optix/OFPM

Habitual Multi-Purpose Solution (MPS) DEVICE

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

Acuvue Oasys/Habitual MPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia; Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, GMA Brand Lead - Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Jessie Lemp, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 22, 2014
• Results First Posted: July 22, 2014

Record last verified: 2014-06