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Completed

NCT Number: NCT00982046

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

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.

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Key information

Conditions

Contact Lenses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visioncare Research Ltd.

Farnham, Surrey, GU9 7EN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opti-Free RepleniSH multi-purpose disinfecting solution

Device

Contact lens solution CE-marked for intended use.

Other names: Opti-Free® RepleniSH®

ReNu MultiPlus Multi-Purpose Solution

Device

Contact lens solution CE-marked for intended use.

Other names: ReNu® MultiPlus®

Clear Care cleaning and disinfecting system

Device

Contact lens care system CE-marked for intended use.

Other names: Clear Care®

Senofilcon A contact lens (ACUVUE OASYS)

Device

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 names: ACUVUE® OASYS™

Lotrafilcon B contact lens (AIR OPTIX AQUA)

Device

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 names: AIR OPTIX® AQUA

Comfilcon A contact lens (Biofinity)

Device

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 names: Biofinity®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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