Back to resultsComparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
somofilcon A 1 day test lens
somofilcon A 1 day control 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;
- Has had a self-reported oculo-visual examination in the last two years;
- Has read, understood, and signed the information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
- Must be able to achieve 20/30 or better (in each eye) with the study lenses;
- Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
- Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
- Has no more than 0.75 diopters of refractive astigmatism;
- Has clear corneas and no active* ocular disease;
- Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
- Is presently participating in any other clinical or research study including eye related clinical or research study;
- Has never worn contact lenses before.
- Has any systemic disease affecting ocular health.
- Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
- Has any known sensitivity to fluorescein dye or products to be used in the study.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Sites / Locations
- Center for Contact Lens Research, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
somofilcon A 1 day test lens
somofilcon A 1 day control lens
Arm Description
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
Outcomes
Primary Outcome Measures
Comfort
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Preference
Overall lens that subject prefers or no preference
Vision
Visual acuity measured in logMAR
Subjective Vision
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Corneal Staining
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Conjunctival Staining
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03372551
Brief Title
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
Official Title
Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
April 23, 2018 (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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
Detailed Description
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.
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
Model Description
This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Masking
ParticipantInvestigator
Masking Description
Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somofilcon A 1 day test lens
Arm Type
Experimental
Arm Description
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
Arm Title
somofilcon A 1 day control lens
Arm Type
Active Comparator
Arm Description
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
Intervention Type
Device
Intervention Name(s)
somofilcon A 1 day test lens
Other Intervention Name(s)
somofilcon A daily disposable test soft contact lens, Invigor I, Test lens
Intervention Description
Contact lens
Intervention Type
Device
Intervention Name(s)
somofilcon A 1 day control lens
Other Intervention Name(s)
somofilcon A daily disposable control soft contact lens, Select 1-Day, Control lens
Intervention Description
Contact lens
Primary Outcome Measure Information:
Title
Comfort
Description
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Time Frame
up to 1 week
Title
Preference
Description
Overall lens that subject prefers or no preference
Time Frame
up to 1 week
Title
Vision
Description
Visual acuity measured in logMAR
Time Frame
Up to 1 week
Title
Subjective Vision
Description
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Time Frame
up to 1 week
Title
Corneal Staining
Description
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
up to 1 week
Title
Conjunctival Staining
Description
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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, understood, and signed the information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
Must be able to achieve 20/30 or better (in each eye) with the study lenses;
Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
Has no more than 0.75 diopters of refractive astigmatism;
Has clear corneas and no active* ocular disease;
Has not worn lenses for at least 12 hours before the examination.
Exclusion Criteria:
Is presently participating in any other clinical or research study including eye related clinical or research study;
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
Has any known sensitivity to fluorescein dye or products to be used in the study.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Facility Information:
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens
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