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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
  Purpose

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).


Condition Intervention Phase
Myopia
Hyperopia
 Device: Silicone Hydrogel Contact Lens
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

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:
  • 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 ]

Secondary Outcome Measures:
  • To quantify comfort and vision ratings with each lens/solution combination. [ Time Frame: over 2 days ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio
Active Comparator: 2 Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio
Active Comparator: 3 Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio
Active Comparator: 4 Device: Silicone Hydrogel Contact Lens
use of lens over 2 days
Other Name: Premio

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.

  Eligibility

Ages Eligible for Study:   17 Years to 55 Years
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520689

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Menicon Co., Ltd.
Investigators
Principal Investigator: Desmond Fonn, M Optom University of Waterloo
Principal Investigator: Craig Woods, PhD University of Waterloo
  More Information

No publications provided

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00520689     History of Changes
Other Study ID Numbers: P/264/07/M
Study First Received: August 22, 2007
Last Updated: February 12, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013