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

This study has been completed.
Sponsor:
Collaborator:
Menicon Co., Ltd.
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00520689
First received: August 22, 2007
Last updated: February 12, 2009
Last verified: February 2009
History of Changes

August 22, 2007
February 12, 2009
September 2007
December 2007   (final data collection date for primary outcome measure)
To see if there are any effects on the cornea when using each contact lens/solution combination. [ Time Frame: Over 2 days ] [ Designated as safety issue: Yes ]
To see if there are any effects on the cornea when using each contact lens/solution combination. [ Time Frame: Over 2 days ]
Complete list of historical versions of study NCT00520689 on ClinicalTrials.gov Archive Site
To quantify comfort and vision ratings with each lens/solution combination. [ Time Frame: over 2 days ] [ Designated as safety issue: Yes ]
To quantify comfort and vision ratings with each lens/solution combination. [ Time Frame: over 2 days ]
Not Provided
Not Provided
 
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

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).

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Myopia
  • Hyperopia
Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
17 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00520689
P/264/07/M
No
Craig Woods, Research Manager, CCLR
University of Waterloo
Menicon Co., Ltd.
Principal Investigator: Desmond Fonn, M Optom University of Waterloo
Principal Investigator: Craig Woods, PhD University of Waterloo
University of Waterloo
February 2009

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