Back to resultsA Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test lens
Control lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
- Requires spectacle lens spherical powers between -1.00 to -5.75 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.
- Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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 enrollment (by verbal confirmation at the screening visit).
Sites / Locations
- University Eye Center at Ketchum Health
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test lens
Control lens
Arm Description
Subjects wearing the test lens for one week, either randomized as the first or second pair.
Subjects wearing the control lens for one week, either randomized as the first or second pair.
Outcomes
Primary Outcome Measures
Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Post Blink Movement
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Post Blink Movement
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Secondary Outcome Measures
Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03951610
Brief Title
A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
Official Title
A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
June 4, 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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
Detailed Description
The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.
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
Double (participant and investigator)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test lens
Arm Type
Experimental
Arm Description
Subjects wearing the test lens for one week, either randomized as the first or second pair.
Arm Title
Control lens
Arm Type
Active Comparator
Arm Description
Subjects wearing the control lens for one week, either randomized as the first or second pair.
Intervention Type
Device
Intervention Name(s)
Test lens
Other Intervention Name(s)
Invigor I DD lens, Somofilcon A 1 day Test
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
Control lens
Other Intervention Name(s)
Clariti 1-day, Somofilcon A 1 day control
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Number of Participants With Lens Centration
Description
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time Frame
Baseline
Title
Number of Participants With Lens Centration
Description
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time Frame
1 week
Title
Post Blink Movement
Description
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time Frame
Baseline
Title
Post Blink Movement
Description
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time Frame
1 week
Title
Primary Gaze Lag
Description
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time Frame
baseline
Title
Primary Gaze Lag
Description
Primary Gaze Lag (measured in mm at 0.1mm steps)
Time Frame
1 week
Title
Up Gaze Lag
Description
Up Gaze Lag (measured in mm at 0.1mm steps)
Time Frame
Baseline
Title
Up Gaze Lag
Description
Up Gaze Lag (measured in mm at 0.1mm steps)
Time Frame
1 week
Title
Push-Up Tightness
Description
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time Frame
baseline
Title
Push-Up Tightness
Description
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time Frame
1 week
Title
Overall Fit Acceptance
Description
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time Frame
Baseline
Title
Overall Fit Acceptance
Description
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time Frame
1 week
Title
Number of Participants With Overall Lens Fit Impression
Description
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time Frame
Baseline
Title
Number of Participants With Overall Lens Fit Impression
Description
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Subjective Comfort Rating
Description
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time Frame
Baseline
Title
Subjective Comfort Rating
Description
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time Frame
1-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
Requires spectacle lens spherical powers between -1.00 to -5.75 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.
Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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 enrollment (by verbal confirmation at the screening visit).
Facility Information:
Facility Name
University Eye Center at Ketchum Health
City
Anaheim
State/Province
California
ZIP/Postal Code
92807
Country
United States
Facility Name
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
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