Back to resultsThe Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
narafilcon A
stenfilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Subjects will only be eligible for the study if:
- They are of legal age (18) and capacity to volunteer.
- 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 agree not to participate in other clinical research for the duration of this study.
- They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
- They have a spectacle cylindrical correction of -0.75D or less in each eye.
- They can be satisfactorily fitted with the study lens types.
- At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They currently use soft contact lenses or have done so in the previous six months.
- They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
- They own a wearable pair of spectacles.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
- 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 have had cataract surgery.
- 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 breast-feeding.
- 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
- They currently wear either the stenfilcon A lens or narafilcon A lens.
Sites / Locations
- Eurolens Research - The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
narafilcon A
stenfilcon A
Arm Description
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
Outcomes
Primary Outcome Measures
Ocular Physiology
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Visual Acuity
Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Comfort Level of Stenfilcon A and Narafilcon A Lenses
Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Dryness of Stenfilcon A and Narafilcon A Lenses
Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).
Vision of Stenfilcon A and Narafilcon A Lenses
Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Lens Movement
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02920970
Brief Title
The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
Official Title
The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.
Detailed Description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
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
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
narafilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
Arm Title
stenfilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
Intervention Type
Device
Intervention Name(s)
narafilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
stenfilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Ocular Physiology
Description
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame
1 week
Title
Visual Acuity
Description
Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Time Frame
1 week
Title
Comfort Level of Stenfilcon A and Narafilcon A Lenses
Description
Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame
1 week
Title
Dryness of Stenfilcon A and Narafilcon A Lenses
Description
Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).
Time Frame
1 week
Title
Vision of Stenfilcon A and Narafilcon A Lenses
Description
Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
Time Frame
1 week
Title
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Description
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time Frame
1 week
Title
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Description
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time Frame
1 week
Title
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Description
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame
1 week
Title
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Description
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time Frame
1 week
Title
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Description
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame
1 week
Title
Lens Movement
Description
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
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:
Subjects will only be eligible for the study if:
They are of legal age (18) and capacity to volunteer.
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 agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
They have a spectacle cylindrical correction of -0.75D or less in each eye.
They can be satisfactorily fitted with the study lens types.
At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.
They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
They own a wearable pair of spectacles.
Exclusion Criteria:
Subjects will not be eligible to take part in the study if:
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 have had cataract surgery.
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 breast-feeding.
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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
They currently wear either the stenfilcon A lens or narafilcon A lens.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD, FAAO, FBCLA
Organizational Affiliation
Eurolens Research, University of Manchester
Official's Role
Study Director
Facility Information:
Facility Name
Eurolens Research - The University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
We'll reach out to this number within 24 hrs