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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520351
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Drug: ClearCare Drug: Optifree Replenish Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: ClearCare
contact lens care system
Active Comparator: 2 Drug: Optifree Replenish
contact lens care system


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520351


Locations
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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
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Principal Investigator: Desmond Fonn, M. Optom University of Waterloo
More Information
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Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00520351    
Other Study ID Numbers: P/265/07/L
First Posted: August 24, 2007    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: September 16, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases