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OpenTrials
Completed

NCT Number: NCT00754338

Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Waterloo, Ontario, N2L3G1, Canada

About this study

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Has read, understood and signed an information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.
  • Is a current soft lens wearer, replacing their lenses every two weeks to one month.
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
  • Has astigmatism less than or equal to -1.00 DC.

Exclusion criteria

  • Has any signs or symptoms of dry eye.
  • Has any clinically significant blepharitis.
  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • Currently wears daily disposable lenses.
  • Currently wears lenses on an extended wear basis.

Treatment and study plan

Alcon Opti-Free® RepleniSH® with Supraclens®

Drug

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

Alcon Opti-Free® RepleniSH®

Drug

Marketed Multipurpose Disinfecting Care System

B&L ReNu MultiPlus™

Drug

Marketed Multipurpose Disinfecting Care Systems

Primary outcomes

  1. Comfort

    Time frame: 4 weeks

    Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.

  2. Lens Wettability

    Time frame: 4 weeks

    Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).

  3. Lens Deposits

    Time frame: 4 weeks

    Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).

Secondary outcomes

  1. Dryness

    Time frame: 4 weeks

    Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.

  2. Subjective Vision

    Time frame: 4 weeks

    Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.

  3. Corneal Staining

    Time frame: 4 weeks

    Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.

    Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.

    A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2008
Registry last updated
Sep 28, 2023

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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