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Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens (Amethyst)

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: NCT00520689
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : February 16, 2009
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by:
University of Waterloo

Tracking Information
First Submitted Date  ICMJE August 22, 2007
First Posted Date  ICMJE August 24, 2007
Last Update Posted Date February 16, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
To see if there are any effects on the cornea when using each contact lens/solution combination. [ Time Frame: Over 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
To quantify comfort and vision ratings with each lens/solution combination. [ Time Frame: over 2 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Official Title  ICMJE Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
Brief Summary The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).
Detailed Description The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Hyperopia
Intervention  ICMJE Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Device: Silicone Hydrogel Contact Lens
  • Active Comparator: 2
    Intervention: Device: Silicone Hydrogel Contact Lens
  • Active Comparator: 3
    Intervention: Device: Silicone Hydrogel Contact Lens
  • Active Comparator: 4
    Intervention: Device: Silicone Hydrogel Contact Lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2007)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  1. Is at least 17 years old and has full legal capacity to volunteer
  2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
  3. Is willing and able to follow instructions and maintain the study appointment schedule
  4. Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
  5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
  6. Has clear corneas and no active ocular disease
  7. Has had an ocular examination in the last two years.
  8. Has a functional pair of spectacles
  9. Is a current soft lens wearer replacing their lenses at least monthly
  10. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
  11. Has astigmatism less than or equal to -1.00DC
  12. Agrees to wear the study lenses on a daily wear basis

Exclusion Criteria:

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

  1. Has any signs or symptoms of dry eye
  2. Has any clinically significant blepharitis
  3. Has undergone corneal refractive surgery
  4. Is aphakic
  5. Has any systemic disease affecting ocular health
  6. Is using any systemic or topical medications that may affect ocular health
  7. Is pregnant or lactating
  8. Is participating in any other type of clinical or research study
  9. Currently wears daily disposable lenses
  10. Currently wears lenses on a continuous or extended wear basis
  11. Is unable to successfully wear contact lenses without routinely using rewetting drops
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520689
Other Study ID Numbers  ICMJE P/264/07/M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig Woods, Research Manager, CCLR
Study Sponsor  ICMJE University of Waterloo
Collaborators  ICMJE Menicon Co., Ltd.
Investigators  ICMJE
Principal Investigator: Desmond Fonn, M Optom University of Waterloo
Principal Investigator: Craig Woods, PhD University of Waterloo
PRS Account University of Waterloo
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP