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

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ClinicalTrials.gov Identifier: NCT01809197
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE March 8, 2013
First Posted Date  ICMJE March 12, 2013
Results First Submitted Date  ICMJE June 25, 2014
Results First Posted Date  ICMJE July 22, 2014
Last Update Posted Date July 22, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" [ Time Frame: Day 30; after 4 hours of lens wear ]
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2013)
Likert Item: "I can comfortably wear my lenses" [ Time Frame: Day 30 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Official Title  ICMJE Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Refractive Error
  • Myopia
  • Hyperopia
  • Astigmatism
  • Presbyopia
Intervention  ICMJE
  • 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: 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: 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™
  • Device: Habitual Multi-Purpose Solution (MPS)
    Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: Lotrafilcon B contact lenses
    • Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
  • 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
    Interventions:
    • Device: Senofilcon A contact lenses
    • Device: Habitual Multi-Purpose Solution (MPS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
387
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2013)
384
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01809197
Other Study ID Numbers  ICMJE M-12-056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jessie Lemp, PhD Alcon Research
PRS Account Alcon Research
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP