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Effects of Contact Lens Care Regimens on the Corneal Epithelium

Primary Purpose

Myopia

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
soft contact lens
Marketed multipurpose disinfection regimen
Sponsored by
University of Waterloo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Is at least 18 years old 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 correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual 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 2 years. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months. An ineligible contact lens wearer is one who: Responds positively to points 1 to 7 above. Has a distance contact lens prescription between -0.50D and -9.00 D. Has astigmatism less than or equal to -1.00D cyl. Currently wears silicone hydrogel contact lenses successfully. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants. Exclusion Criteria: 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 pregnant or lactating. Is participating in any other type of clinical or research study. An ineligible contact lens wearer is one who: Responds positively to any of points 1 to 8 above for exclusion criteria. Has known sensitivity to the contact lens care solutions used in the study. Has ocular or systemic allergies that could adversely affect contact lens wear. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Outcomes

Primary Outcome Measures

The primary outcome measure of this study is to investigate the effects of two
different contact lens care solutions on the cornea.

Secondary Outcome Measures

The secondary outcome measure of this study is to compare the subjective and
objective responses between two different contact lens care solutions.

Full Information

First Posted
July 5, 2006
Last Updated
July 5, 2006
Sponsor
University of Waterloo
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00349882
Brief Title
Effects of Contact Lens Care Regimens on the Corneal Epithelium
Official Title
Effects of Contact Lens Care Regimens on the Corneal Epithelium
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Alcon Research

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.

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 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
soft contact lens
Intervention Type
Drug
Intervention Name(s)
Marketed multipurpose disinfection regimen
Primary Outcome Measure Information:
Title
The primary outcome measure of this study is to investigate the effects of two
Title
different contact lens care solutions on the cornea.
Secondary Outcome Measure Information:
Title
The secondary outcome measure of this study is to compare the subjective and
Title
objective responses between two different contact lens care solutions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Is at least 18 years old 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 correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual 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 2 years. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months. An ineligible contact lens wearer is one who: Responds positively to points 1 to 7 above. Has a distance contact lens prescription between -0.50D and -9.00 D. Has astigmatism less than or equal to -1.00D cyl. Currently wears silicone hydrogel contact lenses successfully. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants. Exclusion Criteria: 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 pregnant or lactating. Is participating in any other type of clinical or research study. An ineligible contact lens wearer is one who: Responds positively to any of points 1 to 8 above for exclusion criteria. Has known sensitivity to the contact lens care solutions used in the study. Has ocular or systemic allergies that could adversely affect contact lens wear. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Woods, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom
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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Effects of Contact Lens Care Regimens on the Corneal Epithelium

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