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A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

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ClinicalTrials.gov Identifier: NCT00982046
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.

Condition or disease Intervention/treatment Phase
Contact Lenses Device: Opti-Free RepleniSH multi-purpose disinfecting solution Device: ReNu MultiPlus multi-purpose solution Device: Clear Care cleaning and disinfecting system Device: Senofilcon A contact lens (ACUVUE OASYS) Device: Lotrafilcon B contact lens (AIR OPTIX AQUA) Device: Comfilcon A contact lens (Biofinity) Not Applicable

Detailed Description:
This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: ACUVUE OASYS
Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
Other Name: Opti-Free® RepleniSH®

Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Name: ReNu® MultiPlus®

Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Name: Clear Care®

Device: Senofilcon A contact lens (ACUVUE OASYS)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Other Name: ACUVUE® OASYS™

Active Comparator: AIR OPTIX AQUA
Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
Other Name: Opti-Free® RepleniSH®

Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Name: ReNu® MultiPlus®

Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Name: Clear Care®

Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Other Name: AIR OPTIX® AQUA

Active Comparator: Biofinity
Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
Other Name: Opti-Free® RepleniSH®

Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Name: ReNu® MultiPlus®

Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Name: Clear Care®

Device: Comfilcon A contact lens (Biofinity)
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Other Name: Biofinity®




Primary Outcome Measures :
  1. Modulus [ Time Frame: 2 weeks ]
    Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens.

  2. Bulbar hyperemia [ Time Frame: 2 weeks ]
    Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed.

  3. Corneal staining type [ Time Frame: 2 weeks ]
    An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score.

  4. Upper palpebral roughness [ Time Frame: 2 weeks ]
    The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed.

  5. High contrast visual acuity [ Time Frame: 2 weeks ]
    High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart.

  6. End of day comfort [ Time Frame: 2 weeks ]
    As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent.



Information from the National Library of Medicine

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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:

  • Signed informed consent.
  • Adapted contact lens wearer for at least one month.
  • Spherical prescription range between +6.00 to -8.00 diopters.
  • Astigmatism of less than or equal to 1.00 diopter in at least one eye.
  • Normal eyes with no evidence of abnormality or disease.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
  • Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
  • Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
  • Eye injury or surgery within 8 weeks prior to study.
  • Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
  • Other protocol-defined exclusion criteria may apply.

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): NCT00982046


Locations
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United Kingdom
Visioncare Research Ltd.
Farnham, Surrey, United Kingdom, GU9 7EN
Sponsors and Collaborators
Alcon Research

Publications of Results:
Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00982046     History of Changes
Other Study ID Numbers: M-09-05
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: July 2012
Keywords provided by Alcon Research:
contact lenses
disinfection solutions
contact lens care
Additional relevant MeSH terms:
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Pharmaceutical Solutions