Back to resultsA Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
comfilcon A
somofilcon A
stenfilcon A
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Subjects will only be eligible for the study if:
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing soft reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
- They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
- They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
- 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.
- 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 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Sites / Locations
- Eurolens Research - The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
somofilcon A then stenfilcon A contact lens
stenfilcon A then somofilcon A contact lens
Arm Description
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
Outcomes
Primary Outcome Measures
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores of Comfort on Insertion
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Secondary Outcome Measures
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores on Overall Comfort
Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores on Comfort Before Removal
Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04005885
Brief Title
A Clinical 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
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 30, 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
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
Detailed Description
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somofilcon A then stenfilcon A contact lens
Arm Type
Experimental
Arm Description
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
Arm Title
stenfilcon A then somofilcon A contact lens
Arm Type
Experimental
Arm Description
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Other Intervention Name(s)
Control Lens
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
somofilcon A
Other Intervention Name(s)
somofilcon A daily disposable test lens, Test lens 1
Intervention Description
daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
stenfilcon A
Other Intervention Name(s)
stenfilcon A daily disposable test lens, Test lens 2
Intervention Description
daily disposable contact lens
Primary Outcome Measure Information:
Title
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Description
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
4 weeks
Title
Subjective Scores of Comfort on Insertion
Description
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Description
Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
4 weeks
Title
Subjective Scores on Overall Comfort
Description
Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
1 week
Title
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Description
Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
4 weeks
Title
Subjective Scores on Comfort Before Removal
Description
Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
1 week
Title
Number of Participants With Horizontal Lens Centration Grade
Description
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Description
Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame
4 weeks
Title
Number of Participants With Horizontal Lens Centration Grade
Description
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time Frame
1 week
Title
Number of Participants With Vertical Lens Centration Grade
Description
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame
Baseline (After 5 minutes of lens dispense)
Title
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Description
Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame
4 weeks
Title
Number of Participants With Vertical Lens Centration Grade
Description
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time Frame
1 week
Title
Number of Participants With Lens Corneal Coverage Grade
Description
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Description
Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
4 weeks
Title
Number of Participants With Lens Corneal Coverage Grade
Description
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
1 week
Title
Number of Participants With Post-Blink Movement Grade
Description
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Description
Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
4 weeks
Title
Number of Participants With Post-Blink Movement Grade
Description
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time Frame
1 week
Title
Investigator Lens Fit Acceptance
Description
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Description
Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame
4 weeks
Title
Investigator Lens Fit Acceptance
Description
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
They are between 18 and 40 years of age (inclusive).
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They are an existing soft reusable spherical contact lens wearer in both eyes.
They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
They own a wearable pair of spectacles and wear them on the day of the initial visit.
They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
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.
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 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research - The University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
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