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

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Silicone Hydrogel Contact Lens
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

To see if there are any effects on the cornea when using each contact lens/solution combination.

Secondary Outcome Measures

To quantify comfort and vision ratings with each lens/solution combination.

Full Information

First Posted
August 22, 2007
Last Updated
February 12, 2009
Sponsor
University of Waterloo
Collaborators
Menicon Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00520689
Brief Title
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Acronym
Amethyst
Official Title
Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Menicon Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Silicone Hydrogel Contact Lens
Other Intervention Name(s)
Premio
Intervention Description
use of lens over 2 days
Primary Outcome Measure Information:
Title
To see if there are any effects on the cornea when using each contact lens/solution combination.
Time Frame
Over 2 days
Secondary Outcome Measure Information:
Title
To quantify comfort and vision ratings with each lens/solution combination.
Time Frame
over 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is at least 17 years old and has full legal capacity to volunteer Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers Is willing and able to follow instructions and maintain the study appointment schedule Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D) Has clear corneas and no active ocular disease Has had an ocular examination in the last two years. Has a functional pair of spectacles Is a current soft lens wearer replacing their lenses at least monthly Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens Has astigmatism less than or equal to -1.00DC Agrees to wear the study lenses on a daily wear basis Exclusion Criteria: A person will be excluded from the study if he/she: Has any signs or symptoms of dry eye Has any clinically significant blepharitis Has undergone corneal refractive surgery Is aphakic Has any systemic disease affecting ocular health Is using any systemic or topical medications that may affect ocular health Is pregnant or lactating Is participating in any other type of clinical or research study Currently wears daily disposable lenses Currently wears lenses on a continuous or extended wear basis Is unable to successfully wear contact lenses without routinely using rewetting drops
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, M Optom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Woods, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

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