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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520689
First Posted: August 24, 2007
Last Update Posted: February 16, 2009
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.
Collaborator:
Menicon Co., Ltd.
Information provided by:
University of Waterloo
  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 (Investigator)
Primary Purpose: Treatment
Official Title: Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 55 Years   (Child, 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 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
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): 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

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00520689     History of Changes
Other Study ID Numbers: P/264/07/M
First Submitted: August 22, 2007
First Posted: August 24, 2007
Last Update Posted: February 16, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases