Back to resultsPerformance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lens A
Lens B
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
- Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
- Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
- Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
Exclusion Criteria:
- Is participating in any concurrent clinical or research study;
- Habitually wears one of the study contact lenses;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- 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 contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Sites / Locations
- Golden Optometric Group
- Golden Vision
- Sacco Eye Group
- Athens Eye Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lens A
Lens B
Arm Description
daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.
Outcomes
Primary Outcome Measures
Overall Ease of Lens Handling
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
Secondary Outcome Measures
Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Visual Acuity
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831515
Brief Title
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Official Title
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (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
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lens A
Arm Type
Experimental
Arm Description
daily disposable soft contact lens - test lens
Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
Arm Title
Lens B
Arm Type
Active Comparator
Arm Description
daily disposable soft contact lens - control lens
Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.
Intervention Type
Device
Intervention Name(s)
Lens A
Intervention Description
daily disposable soft contact lens - test lens
Intervention Type
Device
Intervention Name(s)
Lens B
Intervention Description
daily disposable soft contact lens - control lens
Primary Outcome Measure Information:
Title
Overall Ease of Lens Handling
Description
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Time Frame
Baseline - after lenses have settled for 10 minutes
Title
Visual Acuity
Description
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
Exclusion Criteria:
Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
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 contact lens wear or a study outcome variable;
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
Has undergone refractive error surgery or intraocular surgery.
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
Study Director
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
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