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OpenTrials
Completed

NCT Number: NCT00520351

Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Waterloo, Ontario, N2L3G1, Canada

About this study

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms 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

A person is eligible for inclusion in the study if he/she:

  • 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 presently using either bi-weekly or monthly replacement lenses.
  • Has symptoms of ocular dryness as determined by specific pre-screening criteria.
  • 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.

Exclusion criteria

A person will be excluded from the study if he/she:

  • Is an asymptomatic lens wearer.
  • Is a daily disposable contact lens wearer.
  • Is a current extended wear contact lens wearer.
  • Currently uses one of the study lens care regimens.
  • 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 participating in any other type of clinical or research study.

Treatment and study plan

ClearCare

Drug

contact lens care system

Optifree Replenish

Drug

contact lens care system

Primary outcomes

  1. High Contrast Visual Acuity

    Time frame: 2 weeks

    High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.

    10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.

  2. Low Contrast Visual Acuity

    Time frame: 2 weeks

    Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.

    10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.

  3. In-vivo Wettability

    Time frame: 2 weeks

    Pre-lens non-invasive tear breakup time

  4. Subjective Comfort Rating

    Time frame: 2 weeks

    Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2007
Registry last updated
Sep 16, 2010

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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