search
Back to results

One Week Assessment of The Phenacite Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phenacite (Test) contact lens
comfilcon A contact lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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 (Diopter) and -4.50D
    • Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
    • 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.
    • Has any systemic disease affecting ocular health.
    • Is using any systemic or topical medications that will affect ocular health.
    • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
    • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
    • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
    • Is aphakic.
    • Has undergone corneal refractive surgery.
    • Is participating in any other type of eye related clinical or research study.

Sites / Locations

  • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phenacite contact lens

comfilcon A contact lens

Arm Description

Study Test Contact Lens

Control Contact Lens

Outcomes

Primary Outcome Measures

Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Subjective Ratings for Distance Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Subjective Ratings for Intermediate Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Subjective Ratings for Near Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)

Secondary Outcome Measures

Post Blink Movement -
Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Subjective Lens Preference - Distance Vision
Patient subjective preference: Phenacite lens, comfilcon A or No Preference
Subjective Lens Preference -Overall Vision Preference
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Subjective Lens Preference - Comfort
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Subjective Overall Lens Preference
Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference

Full Information

First Posted
September 14, 2015
Last Updated
November 30, 2020
Sponsor
Coopervision, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02553395
Brief Title
One Week Assessment of The Phenacite Lens
Official Title
One Week Assessment of The Phenacite Lens
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (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 will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.
Detailed Description
This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear. The study test lens was not the final optical design and the study results were not used for the design validation.

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
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenacite contact lens
Arm Type
Experimental
Arm Description
Study Test Contact Lens
Arm Title
comfilcon A contact lens
Arm Type
Active Comparator
Arm Description
Control Contact Lens
Intervention Type
Device
Intervention Name(s)
Phenacite (Test) contact lens
Intervention Type
Device
Intervention Name(s)
comfilcon A contact lens
Primary Outcome Measure Information:
Title
Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Description
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time Frame
Baseline - After 5 minutes of lens settling
Title
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Description
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Time Frame
1 week
Title
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Description
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time Frame
Baseline - after 5 minutes of lens dispense
Title
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Description
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Time Frame
1-week
Title
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Description
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame
Baseline (After 5 minutes of lens settling)
Title
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Description
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame
1 week
Title
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Description
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame
Baseline (after 5 minutes of lens settling)
Title
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Description
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Time Frame
1week
Title
Subjective Ratings for Distance Quality of Vision
Description
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time Frame
1 week
Title
Subjective Ratings for Intermediate Quality of Vision
Description
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time Frame
1 week
Title
Subjective Ratings for Near Quality of Vision
Description
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Post Blink Movement -
Description
Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame
Baseline (After 5 minutes of lens dispense)
Title
Post Blink Movement
Description
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame
1 week
Title
Push - Up Test for Lens Tightness
Description
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time Frame
Baseline (After 5 minutes of lens dispense)
Title
Push - Up Test for Lens Tightness
Description
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time Frame
1 week
Title
Lens Mobility Rating
Description
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Lens Mobility Rating
Description
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Time Frame
1 week
Title
Overall Lens Fit Acceptance
Description
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time Frame
Baseline (After 5 minutes of lens dispense)
Title
Overall Lens Fit Acceptance
Description
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time Frame
1 week
Title
Subjective Lens Preference - Distance Vision
Description
Patient subjective preference: Phenacite lens, comfilcon A or No Preference
Time Frame
1 week
Title
Subjective Lens Preference -Overall Vision Preference
Description
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Time Frame
1 week
Title
Subjective Lens Preference - Comfort
Description
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Time Frame
1 week
Title
Subjective Overall Lens Preference
Description
Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference
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 (Diopter) and -4.50D Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75 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. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kollbaum, OD, PhD
Organizational Affiliation
Clinical Optics Research Lab (CORL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

One Week Assessment of The Phenacite Lens

We'll reach out to this number within 24 hrs