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

NCT ID: NCT01809197

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-07-31

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.

Conditions

Refractive Error; Myopia; Hyperopia; Astigmatism; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Lotrafilcon B contact lenses

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Senofilcon A contact lenses

Intervention Type: DEVICE

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

Habitual Multi-Purpose Solution (MPS)

Intervention Type: DEVICE

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

Interventions

Lotrafilcon B contact lenses

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

Intervention Type: DEVICE

Senofilcon A contact lenses

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Habitual Multi-Purpose Solution (MPS)

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

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® AQUA; AIR OPTIX® AQUA Multifocal; AIR OPTIX® for Astigmatism; ACUVUE® OASYS® with HYDRACLEAR® PLUS; ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS; ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS; OPTI-FREE® PureMoist™

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessie Lemp, PhD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-12-056

Identifier Type: -

Identifier Source: org_study_id