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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01809197
First received: March 8, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" [ Time Frame: Day 30; after 4 hours of lens wear ] [ Designated as safety issue: No ]
    Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.


Enrollment: 387
Study Start Date: April 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809197

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01809197     History of Changes
Other Study ID Numbers: M-12-056
Study First Received: March 8, 2013
Results First Received: June 25, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Refractive error
Myopia
Hyperopia
Astigmatism
Presbyopia
Contact lenses
Contact lens solution
Comfort

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Presbyopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014