Back to resultsA Clinical Comparison of Three Soft Daily Disposable Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
somofilcon A
nelfilcon A II 2
omafilcon A ll 2
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.
- 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 five days per week and for at least eight hours per day).
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.
Sites / Locations
- Eurolens Research - The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
somofilcon A
nelfilcon A II 2
omafilcon A ll 2
Arm Description
Subjects are randomized to wear somofilcon A for one week during the cross over study.
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
Outcomes
Primary Outcome Measures
Ocular Physiology
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Secondary Outcome Measures
Lens Fit - Horizontal Centration
Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Lens Fit - Vertical Centration
Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Fit - Corneal Coverage
Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Fit - Movement
Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Lens Surface - Deposition
Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Lens Surface - Wettability
Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Visual Acuity
Visual acuity will be assessed by LogMAR.
Full Information
NCT ID
NCT02920983
First Posted
September 29, 2016
Last Updated
October 15, 2019
Sponsor
Coopervision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02920983
Brief Title
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
Official Title
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 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 of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.
Detailed Description
This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in 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
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somofilcon A
Arm Type
Active Comparator
Arm Description
Subjects are randomized to wear somofilcon A for one week during the cross over study.
Arm Title
nelfilcon A II 2
Arm Type
Active Comparator
Arm Description
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
Arm Title
omafilcon A ll 2
Arm Type
Active Comparator
Arm Description
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
Intervention Type
Device
Intervention Name(s)
somofilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
nelfilcon A II 2
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A ll 2
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Ocular Physiology
Description
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Lens Fit - Horizontal Centration
Description
Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time Frame
1 week
Title
Lens Fit - Vertical Centration
Description
Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame
1 week
Title
Lens Fit - Corneal Coverage
Description
Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame
1 week
Title
Lens Fit - Movement
Description
Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame
1 week
Title
Lens Surface - Deposition
Description
Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame
1 week
Title
Lens Surface - Wettability
Description
Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame
1 week
Title
Visual Acuity
Description
Visual acuity will be assessed by LogMAR.
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.
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 five days per week and for at least eight hours per day).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Maldonado-Codinal, PhD, FAAO
Organizational Affiliation
Eurolens Research, University of Manchester
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
Plan to Share IPD
No
Learn more about this trial
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
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