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Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
ClearCare
Optifree Replenish
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 - undefined (Child, Adult, Older 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 of age and has full legal capacity to volunteer.
  2. Has read, understood and signed an information consent letter.
  3. Is willing and able to follow instructions and maintain the appointment schedule.
  4. Is presently using either bi-weekly or monthly replacement lenses.
  5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
  6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  7. Has clear corneas and no active ocular disease.
  8. Has had an ocular examination in the last two years.

Exclusion Criteria:

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

  1. Is an asymptomatic lens wearer.
  2. Is a daily disposable contact lens wearer.
  3. Is a current extended wear contact lens wearer.
  4. Currently uses one of the study lens care regimens.
  5. Has any clinically significant blepharitis.
  6. Has undergone corneal refractive surgery.
  7. Is aphakic.
  8. Has any active ocular disease.
  9. Has any systemic disease affecting ocular health.
  10. Is using any systemic or topical medications that may affect ocular health.
  11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  12. Is participating in any other type of clinical or research study.

Sites / Locations

  • Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

High Contrast Visual Acuity
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Low Contrast Visual Acuity
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
In-vivo Wettability
Pre-lens non-invasive tear breakup time
Subjective Comfort Rating
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2007
Last Updated
August 20, 2010
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00520351
Brief Title
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Official Title
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
Detailed Description
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ClearCare
Intervention Description
contact lens care system
Intervention Type
Drug
Intervention Name(s)
Optifree Replenish
Intervention Description
contact lens care system
Primary Outcome Measure Information:
Title
High Contrast Visual Acuity
Description
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Time Frame
2 weeks
Title
Low Contrast Visual Acuity
Description
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Time Frame
2 weeks
Title
In-vivo Wettability
Description
Pre-lens non-invasive tear breakup time
Time Frame
2 weeks
Title
Subjective Comfort Rating
Description
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 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 of age and has full legal capacity to volunteer. Has read, understood and signed an information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is presently using either bi-weekly or monthly replacement lenses. Has symptoms of ocular dryness as determined by specific pre-screening criteria. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. Has clear corneas and no active ocular disease. Has had an ocular examination in the last two years. Exclusion Criteria: A person will be excluded from the study if he/she: Is an asymptomatic lens wearer. Is a daily disposable contact lens wearer. Is a current extended wear contact lens wearer. Currently uses one of the study lens care regimens. Has any clinically significant blepharitis. Has undergone corneal refractive surgery. Is aphakic. Has any active ocular disease. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that may affect ocular health. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. Is participating in any other type of clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, M. Optom
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, School of Optometry, University of Waterloo.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada

12. IPD Sharing Statement

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Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)

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