Back to resultsA Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
Primary Purpose
Astigmatism Bilateral
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Comfilcon A (test)
Senofilcon C (control)
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism Bilateral
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 had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
- Is willing to wear contact lens in both eyes for the duration of the study;
- Has a minimum astigmatism of - 0.75, determined by refraction;
- Can be fit with the two study contact lens types in the powers available;
- Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
- Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
- Has clear corneas and no active* ocular disease;
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study measure;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- Has known sensitivity to fluorescein dye or products to be used in the study;
- Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Has participated in the previous QUENA study.
Sites / Locations
- University Of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Comfilcon A (test)
Senofilcon C (control)
Arm Description
Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Outcomes
Primary Outcome Measures
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion (Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion(Handling)
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Secondary Outcome Measures
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation
Rotational Recovery After Lens Mislocation
Lens relocation after 10 blinks, after 30º rotation mislocation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03684928
Brief Title
A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
Official Title
A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
February 1, 2019 (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
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
Detailed Description
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comfilcon A (test)
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Arm Title
Senofilcon C (control)
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Intervention Type
Device
Intervention Name(s)
Comfilcon A (test)
Intervention Description
Daily wear contact lenses
Intervention Type
Device
Intervention Name(s)
Senofilcon C (control)
Intervention Description
Daily wear contact lenses
Primary Outcome Measure Information:
Title
Ease of Insertion(Handling)
Description
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time Frame
Baseline
Title
Ease of Insertion (Handling)
Description
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time Frame
2 weeks
Title
Ease of Insertion(Handling)
Description
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Rotational Recovery After Lens Mislocation
Description
Lens relocation after 10 blinks, after 30º rotation mislocation
Time Frame
Baseline
Title
Rotational Recovery After Lens Mislocation
Description
Lens relocation after 10 blinks, after 30º rotation mislocation.
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:
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 had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
Is willing to wear contact lens in both eyes for the duration of the study;
Has a minimum astigmatism of - 0.75, determined by refraction;
Can be fit with the two study contact lens types in the powers available;
Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
Has clear corneas and no active* ocular disease;
Exclusion Criteria:
A person will be excluded from the study if he/she:
Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
Has known sensitivity to fluorescein dye or products to be used in the study;
Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;
Has participated in the previous QUENA study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
Director, Centre for Ocular Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
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