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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809197


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, PhD Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01809197     History of Changes
Other Study ID Numbers: M-12-056
First Posted: March 12, 2013    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Myopia
Astigmatism
Presbyopia
Refractive Errors
Hyperopia
Eye Diseases
 Pharmaceutical Solutions
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents