Back to resultsTo Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lens A (lehfilcon A lens)
Lens B (comfilcon A lens)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Self-reports having had a full eye examination within the previous 2 years;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a habitual wearer of frequent replacement contact lenses;
- Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be successfully fit with both study lens types;
- Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Exclusion Criteria:
- Is participating in any concurrent clinical research study;
- Has any known active* ocular disease and/or infection;
- Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Is an employee of the Centre for Ocular Research & Education.
Sites / Locations
- School of Optometry & Vision Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lens A, Then Lens B
Lens B, Then Lens A
Arm Description
Participants wore Lens A for one month and then crossed over to wear Lens B for one month.
Participants wore Lens B for one month and then crossed over to wear Lens A for one month.
Outcomes
Primary Outcome Measures
Lens Handling on Lens Removal
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05333965
Brief Title
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Official Title
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Detailed Description
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lens A, Then Lens B
Arm Type
Experimental
Arm Description
Participants wore Lens A for one month and then crossed over to wear Lens B for one month.
Arm Title
Lens B, Then Lens A
Arm Type
Experimental
Arm Description
Participants wore Lens B for one month and then crossed over to wear Lens A for one month.
Intervention Type
Device
Intervention Name(s)
Lens A (lehfilcon A lens)
Intervention Description
Daily wear for 1 month.
Intervention Type
Device
Intervention Name(s)
Lens B (comfilcon A lens)
Intervention Description
Daily wear for 1 month.
Primary Outcome Measure Information:
Title
Lens Handling on Lens Removal
Description
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 17 years of age and has full legal capacity to volunteer;
Self-reports having had a full eye examination within the previous 2 years;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a habitual wearer of frequent replacement contact lenses;
Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
Has refractive astigmatism no higher than -0.75DC in each eye;
Can be successfully fit with both study lens types;
Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Exclusion Criteria:
Is participating in any concurrent clinical research study;
Has any known active ocular disease and/or infection;
Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
Is an employee of the Centre for Ocular Research & Education.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
Centre for Ocular Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry & Vision Science
City
Waterloo
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
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