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

November 15, 2016 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Farnham, Surrey, United Kingdom, GU9 7EN
        • Visioncare Research Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Opti-Free® RepleniSH®
Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Names:
  • ReNu® MultiPlus®
Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Names:
  • 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 Names:
  • 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 Names:
  • Opti-Free® RepleniSH®
Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Names:
  • ReNu® MultiPlus®
Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Names:
  • 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 Names:
  • 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 Names:
  • Opti-Free® RepleniSH®
Device: ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
Other Names:
  • ReNu® MultiPlus®
Device: Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
Other Names:
  • 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 Names:
  • Biofinity®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (ESTIMATE)

September 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-09-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contact Lenses

Clinical Trials on Opti-Free RepleniSH multi-purpose disinfecting solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe