Back to resultsEvaluation of the Performance of Non-molded Soft Contact Lenses
Primary Purpose
Ametropia
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Soft contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Ametropia
Eligibility Criteria
Inclusion Criteria:
- Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.
Exclusion Criteria:
- Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Sites / Locations
- Centre for Contact Lens Research, University of Waterloo,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
soft contact lens
non-lens wear
Arm Description
control group
Outcomes
Primary Outcome Measures
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Visual Acuity
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Neovascularisation
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Neovascularization
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Secondary Outcome Measures
Full Information
NCT ID
NCT00371787
First Posted
September 1, 2006
Last Updated
January 5, 2011
Sponsor
University of Waterloo
Collaborators
CIBA VISION
1. Study Identification
Unique Protocol Identification Number
NCT00371787
Brief Title
Evaluation of the Performance of Non-molded Soft Contact Lenses
Official Title
Evaluation of the Performance of Non-molded Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Waterloo
Collaborators
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
Detailed Description
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
soft contact lens
Arm Type
Experimental
Arm Title
non-lens wear
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
Soft contact lens
Other Intervention Name(s)
Custom O2Optix
Intervention Description
Soft contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Time Frame
baseline
Title
Visual Acuity
Description
level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.
Time Frame
9 month
Title
Neovascularisation
Description
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Time Frame
baseline
Title
Neovascularization
Description
length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.
Time Frame
9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.
Exclusion Criteria:
Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn
Organizational Affiliation
Centre for Contact Lens Research
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
Learn more about this trial
Evaluation of the Performance of Non-molded Soft Contact Lenses
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