Back to resultsRefitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
somofilcon A
etafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
- Demonstrates an acceptable fit with the study lenses;
Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research & Education;
- Has participated in the BEAGLE (EX-MKTG-104) study.
Sites / Locations
- University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
somofilcon A
etafilcon A
Arm Description
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.
Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
Outcomes
Primary Outcome Measures
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Secondary Outcome Measures
Lens Centration
Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus)
Lens Centration
Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus)
Post-blink Movement
Post-blink movement in primary gaze, in 0.1mm steps
Post-blink Movement
Post-blink movement in primary gaze, in 0.1mm steps
Push-up Tightness
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Push-up Tightness
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04195893
Brief Title
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
Official Title
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 24, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
March 11, 2020 (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 objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.
Detailed Description
The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).
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
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somofilcon A
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.
Arm Title
etafilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
Intervention Type
Device
Intervention Name(s)
somofilcon A
Other Intervention Name(s)
Clariti 1-Day
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
1-Day Acuvue Moist
Intervention Description
Contact Lens
Primary Outcome Measure Information:
Title
Lens Handling for Lens Insertion
Description
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 1
Title
Lens Handling for Lens Insertion
Description
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 3
Title
Lens Handling for Lens Insertion
Description
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 5
Title
Lens Handling for Lens Insertion
Description
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
1 Week
Title
Lens Handling for Lens Removal
Description
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 1
Title
Lens Handling for Lens Removal
Description
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 3
Title
Lens Handling for Lens Removal
Description
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
Day 5
Title
Lens Handling for Lens Removal
Description
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Centration
Description
Lens Centration was measured on a scale of 0-3 (0 - optimal, 1 - slight decentration, 2- moderate decentration but not encroaching limbus, 3 - excessive & occasionally encroaching limbus)
Time Frame
Baseline (after 10 minutes of lens fitting)
Title
Lens Centration
Description
Lens Centration was measured on a scale of 0 - 3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3-excessive & occasionally encroaching limbus)
Time Frame
1 week
Title
Post-blink Movement
Description
Post-blink movement in primary gaze, in 0.1mm steps
Time Frame
Baseline (after 10 minutes of lens fitting)
Title
Post-blink Movement
Description
Post-blink movement in primary gaze, in 0.1mm steps
Time Frame
1 -week
Title
Push-up Tightness
Description
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time Frame
Baseline (after 10 minutes of lens fitting)
Title
Push-up Tightness
Description
Push-up tightness in primary gaze was measured using a scale 0-100 (5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Subjective Ratings of Comfort After Lens Insertion
Description
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame
Baseline
Title
Subjective Ratings of Comfort After Lens Insertion
Description
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame
1 Day
Title
Subjective Ratings of Comfort After Lens Insertion
Description
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame
Day 3
Title
Subjective Ratings of Comfort After Lens Insertion
Description
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame
Day 5
Title
Subjective Ratings of Comfort After Lens Insertion
Description
Subjective Ratings of Comfort After Lens Insertion was measured on a scale of 0-10 (0-Painful, 10- Can't feel the lenses).
Time Frame
1-Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
Demonstrates an acceptable fit with the study lenses;
Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;
Is an employee of the Centre for Ocular Research & Education;
Has participated in the BEAGLE (EX-MKTG-104) study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones
Organizational Affiliation
University of Waterloo
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
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses
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