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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00520351
First received: August 21, 2007
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Myopia
 Drug: ClearCare
Drug: Optifree Replenish
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • High Contrast Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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.


  • Low Contrast Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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.


  • In-vivo Wettability [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Pre-lens non-invasive tear breakup time

  • Subjective Comfort Rating [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.


Enrollment: 30
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ClearCare
contact lens care system
Other Name: ClearCare
Active Comparator: 2 Drug: Optifree Replenish
contact lens care system
Other Name: Optifree Replenish

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

  1. Is at least 17 years of age and has full legal capacity to volunteer.
  2. Has read, understood and signed an information consent letter.
  3. Is willing and able to follow instructions and maintain the appointment schedule.
  4. Is presently using either bi-weekly or monthly replacement lenses.
  5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
  6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  7. Has clear corneas and no active ocular disease.
  8. Has had an ocular examination in the last two years.

Exclusion Criteria:

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

  1. Is an asymptomatic lens wearer.
  2. Is a daily disposable contact lens wearer.
  3. Is a current extended wear contact lens wearer.
  4. Currently uses one of the study lens care regimens.
  5. Has any clinically significant blepharitis.
  6. Has undergone corneal refractive surgery.
  7. Is aphakic.
  8. Has any active ocular disease.
  9. Has any systemic disease affecting ocular health.
  10. Is using any systemic or topical medications that may affect ocular health.
  11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  12. Is participating in any other type of clinical or research study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520351

Locations
Canada, Ontario
Centre for Contact Lens Research, School of Optometry, University of Waterloo.
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Desmond Fonn, M. Optom University of Waterloo
  More Information

No publications provided

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00520351     History of Changes
Other Study ID Numbers: P/265/07/L
Study First Received: August 21, 2007
Results First Received: March 26, 2010
Last Updated: August 20, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013