Back to resultsComparison of Two Daily Disposable Soft Contact Lenses
Primary Purpose
Astigmatism Bilateral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
midafilcon A
somofilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism Bilateral
Eligibility Criteria
Inclusion Criteria:
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
- At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria:
- They have an ocular disorder, which would normally contra-indicate contact lens wear.
- They have a systemic disorder, which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breastfeeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Sites / Locations
- CooperVision Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
midafilcon A
somofilcon A
Arm Description
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
Outcomes
Primary Outcome Measures
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Secondary Outcome Measures
Subjective Score for Vision
Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Subjective Score for Vision
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Full Information
NCT ID
NCT03779503
First Posted
December 13, 2018
Last Updated
September 14, 2020
Sponsor
Coopervision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03779503
Brief Title
Comparison of Two Daily Disposable Soft Contact Lenses
Official Title
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
September 18, 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 was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Detailed Description
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
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
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
midafilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
Arm Title
somofilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
Intervention Type
Device
Intervention Name(s)
midafilcon A
Intervention Description
midafilcon A 1 day daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
somofilcon A
Intervention Description
somofilcon A 1 day daily disposable contact lens
Primary Outcome Measure Information:
Title
Lens Fit - Horizontal Centration
Description
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Time Frame
Baseline
Title
Lens Fit - Horizontal Centration
Description
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Time Frame
One Week
Title
Lens Fit - Vertical Centration
Description
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Time Frame
Baseline
Title
Lens Fit - Vertical Centration
Description
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Time Frame
One Week
Title
Lens Fit - Corneal Coverage
Description
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time Frame
Baseline
Title
Lens Fit - Corneal Coverage
Description
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time Frame
One Week
Title
Lens Fit - Lens Movement
Description
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time Frame
Baseline
Title
Lens Fit - Lens Movement
Description
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Time Frame
One Week
Secondary Outcome Measure Information:
Title
Subjective Score for Vision
Description
Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Time Frame
Baseline
Title
Subjective Score for Vision
Description
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
They are between 18 and 40 years of age (inclusive).
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
They own a wearable pair of spectacles and wear them on the day of the initial visit.
At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria:
They have an ocular disorder, which would normally contra-indicate contact lens wear.
They have a systemic disorder, which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or breastfeeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD MCOptom FAAO FBCLA
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CooperVision Inc.
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Daily Disposable Soft Contact Lenses
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