Back to resultsDispensing Study for a New Study Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Phenacite
comfilcon A
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:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has previously participated in study of the Phenacite lenses
Sites / Locations
- University of California
- CORL, Indiana University
- Center for Contact Lens Research, University of Waterloo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Phenacite Test lens then comfilcon A control lens
Comfilcon A control lens then Phenacite test Lens
Arm Description
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Outcomes
Primary Outcome Measures
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Secondary Outcome Measures
Biomicroscopy Findings - Bulbar Hyperemia
Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Biomicroscopy Findings- Limbal Hyperemia
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Biomicroscopy Findings - Corneal Staining Extent
Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area
Ghosting - Distance Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Ghosting - Near Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Overall Comfort
Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Overall Comfort
Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Lens Preference - Overall Vision Preference
Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Subjective Ratings of Change in Frequency of Tiredness
Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Ratings of Change in Severity of Tiredness
Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Ratings of Change in Bothersome Rating for Tiredness
Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Ratings of Change in Frequency of Dryness
Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Ratings of Change in Severity of Dryness
Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Ratings of Change in Bothersome Rating of Dryness
Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Subjective Questionnaire Response - Eye Strain
Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Subjective Questionnaire Response - Eye Feel Good
Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Subjective Questionnaire Response - Eye Feel Relaxed
Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Subjective Questionnaire Response - Vision
Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Subjective Questionnaire Response - Eye Tired
Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02642991
Brief Title
Dispensing Study for a New Study Lens
Official Title
Dispensing Study for The Phenacite Project
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (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 study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.
Detailed Description
This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily 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
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenacite Test lens then comfilcon A control lens
Arm Type
Experimental
Arm Description
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Arm Title
Comfilcon A control lens then Phenacite test Lens
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
Intervention Type
Device
Intervention Name(s)
Phenacite
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) - High Illumination
Description
Distance visual acuity High Illumination was assessed using logMAR
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Distance Visual Acuity (VA) - High Illumination
Description
Distance visual acuity High Illumination was assessed using logMAR
Time Frame
1 week
Title
Near Visual Acuity (VA) - High Illumination
Description
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Near Visual Acuity (VA) - High Illumination
Description
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time Frame
1 week
Title
Distance Visual Acuity (VA) - Low Illumination
Description
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Distance Visual Acuity (VA) - Low Illumination
Description
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time Frame
1 week
Title
Near Visual Acuity (VA) - Low Illumination
Description
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Near Visual Acuity (VA) - Low Illumination
Description
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time Frame
1 week
Title
Quality of Distance Vision
Description
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Quality of Distance Vision
Description
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
1 week
Title
Quality of Near Vision
Description
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time Frame
Baseline (After 10 minutes of lens dispense)
Title
Quality of Near Vision
Description
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time Frame
1 week
Title
Quality of Vision With Digital Device Use
Description
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
Baseline (After 10 minutes of lens dispense)
Title
Quality of Vision With Digital Device Use
Description
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
1 week
Title
Quality of Intermediate Vision
Description
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
Baseline (After 10 minutes of lens dispense)
Title
Quality of Intermediate Vision
Description
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
1 week
Title
Overall Vision Quality
Description
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
Baseline (After 10 minutes of lens dispense)
Title
Overall Vision Quality
Description
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Biomicroscopy Findings - Bulbar Hyperemia
Description
Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time Frame
1 week
Title
Biomicroscopy Findings- Limbal Hyperemia
Description
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time Frame
1 week
Title
Biomicroscopy Findings - Corneal Staining Extent
Description
Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area
Time Frame
1 week
Title
Ghosting - Distance Vision
Description
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time Frame
1 week
Title
Ghosting - Near Vision
Description
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time Frame
1 week
Title
Overall Comfort
Description
Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time Frame
Baseline (After 10 minutes of lens dispense)
Title
Overall Comfort
Description
Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time Frame
1 week
Title
Overall Dryness
Description
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time Frame
Baseline (after 10 minutes of lens dispense)
Title
Overall Dryness
Description
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time Frame
1 week
Title
Lens Preference - Overall Vision Preference
Description
Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Time Frame
1 week
Title
Subjective Ratings of Change in Frequency of Tiredness
Description
Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Ratings of Change in Severity of Tiredness
Description
Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Ratings of Change in Bothersome Rating for Tiredness
Description
Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Ratings of Change in Frequency of Dryness
Description
Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Ratings of Change in Severity of Dryness
Description
Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Ratings of Change in Bothersome Rating of Dryness
Description
Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time Frame
1 week
Title
Subjective Questionnaire Response - Eye Strain
Description
Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Time Frame
1 week
Title
Subjective Questionnaire Response - Eye Feel Good
Description
Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Time Frame
1 week
Title
Subjective Questionnaire Response - Eye Feel Relaxed
Description
Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Time Frame
1 week
Title
Subjective Questionnaire Response - Vision
Description
Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Time Frame
1 week
Title
Subjective Questionnaire Response - Eye Tired
Description
Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Oculo-visual examination in the last two years
Between 18 and 35 years of age and has full legal capacity to volunteer
Has read and understood the informed consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
Has not worn lenses for at least 12 hours before the initial visit
Has a subjective response at baseline, which indicates suitability for this study
Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week
Exclusion Criteria:
A person will be excluded from the study if he/she:
Has never worn contact lenses before
Any systemic disease affecting ocular health
Is using any systemic or topical medications that will affect ocular health
Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
Has any ocular pathology or anomaly that would affect the wearing of the lenses
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
Is aphakic
Has anisometropia of >1.00
Has undergone corneal refractive surgery
Has strabismus
Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
Is participating in any other type of eye related clinical or research study
Has previously participated in study of the Phenacite lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones
Organizational Affiliation
CCLR, University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pete Kollbaum, OD, PhD
Organizational Affiliation
CORL, Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meng Lin, OD, PhD
Organizational Affiliation
CRC, University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Facility Name
CORL, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dispensing Study for a New Study Lens
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