Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
comfilcon A
senofilcon C
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 34 years of age (inclusive)
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Has a contact lens prescription that fits within the available parameters of the study lenses.
- Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
- Presents with clinically significant anterior segment abnormalities
- Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (or history in past year)
- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Is currently wearing daily disposable lenses
Sites / Locations
- Golden Optometric Group
- Coan Eye Care & Optical Boutique
- Cornea & Contact Lens Institute of Minnesota
- Sacco Eye Group
- Vision Professionals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
comfilcon A
senofilcon C
Arm Description
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
Outcomes
Primary Outcome Measures
Overall Lens Fit Acceptance
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Corneal Coverage
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Lens Centration
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Post-blink Movement
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Lens Lag at Primary Gaze
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Tightness on Push up
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Lens Wettability
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Deposit Grading
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Secondary Outcome Measures
Full Information
NCT ID
NCT02920957
First Posted
September 29, 2016
Last Updated
December 11, 2017
Sponsor
Coopervision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02920957
Brief Title
Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Official Title
Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 23, 2016 (Actual)
Study Completion Date
November 23, 2016 (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
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.
Detailed Description
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
comfilcon A
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
Arm Title
senofilcon C
Arm Type
Active Comparator
Arm Description
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon C
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Overall Lens Fit Acceptance
Description
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Time Frame
Up to 1 month
Title
Corneal Coverage
Description
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Time Frame
Up to 1 month
Title
Lens Centration
Description
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Time Frame
Up to 1 month
Title
Post-blink Movement
Description
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Time Frame
Up to 1 month
Title
Lens Lag at Primary Gaze
Description
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Time Frame
Up to 1 month
Title
Tightness on Push up
Description
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Time Frame
Up to 1 month
Title
Lens Wettability
Description
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Time Frame
Up to 1 month
Title
Deposit Grading
Description
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Is between 18 and 34 years of age (inclusive)
Has had a self-reported eye exam in the last two years
Is a spherical soft contact lens wearer
Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Has a contact lens prescription that fits within the available parameters of the study lenses.
Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule
Exclusion Criteria:
A person will be excluded from the study if he/she:
Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
Significant pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (or history in past year)
Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Is habitually using rewetting/ lubricating eye drops more than once per day
Is currently wearing daily disposable lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD, FAAO, FIACLE, FBCLA
Organizational Affiliation
Centre for Contact Lens Research
Official's Role
Study Director
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Coan Eye Care & Optical Boutique
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Cornea & Contact Lens Institute of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55436
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Vision Professionals
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Performance Comparison Between Comfilcon A and Senofilcon C Lenses
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