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Dispensing Study for the Phenacite Project

Primary Purpose

Ametropia

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

About this trial

This is an interventional treatment trial for Ametropia

Eligibility Criteria

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

Inclusion Criteria:

  • 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 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:

  • 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 Visual Acuity
  • Is participating in any other type of eye related clinical or research study
  • Has participated in study CV-14-32.

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

comfilcon A

Arm Description

Subjects will be randomized to wear the Phenacite contact lenses binocularly.

Subjects will be randomized to wear the comfilcon A contact lenses binocularly.

Outcomes

Primary Outcome Measures

Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Over Refraction for Optimized Distance Acuity
Over Refraction for optimized distance acuity measured using logMAR
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR

Secondary Outcome Measures

Lens Fit - Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Lens Fit - 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 Ratings for Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale 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 Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale 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 Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale 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
Subjective Ratings for Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale 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
Subjective Ratings for Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer 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 Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer 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 Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall 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 Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall 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
Corneal Staining Extent
Corneal staining extent was assessed 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
Conjunctival Staining
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent

Full Information

First Posted
May 1, 2015
Last Updated
October 30, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02436005
Brief Title
Dispensing Study for the Phenacite Project
Official Title
Dispensing Study for the Phenacite Project
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dispensing Study for the Phenacite Project. The investigational test lens was not the final optical design and the study was not used for design validation.
Detailed Description
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenacite
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Arm Title
comfilcon A
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Intervention Type
Device
Intervention Name(s)
Phenacite
Intervention Description
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention Description
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Primary Outcome Measure Information:
Title
Subjective Ratings of Lens Comfort
Description
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Subjective Ratings of Lens Comfort
Description
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time Frame
2 Weeks
Title
Over Refraction for Optimized Distance Acuity
Description
Over Refraction for optimized distance acuity measured using logMAR
Time Frame
2 weeks
Title
Binocular Distance Visual Acuity - High Illumination High Contrast
Description
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Binocular Distance Visual Acuity - High Illumination High Contrast
Description
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame
2 weeks
Title
Binocular Distance Visual Acuity - Low Illumination High Contrast
Description
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Binocular Distance Visual Acuity - Low Illumination High Contrast
Description
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame
2 weeks
Title
Binocular Near Visual Acuity - High Illumination High Contrast
Description
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Binocular Near Visual Acuity - High Illumination High Contrast
Description
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time Frame
2 weeks
Title
Binocular Near Visual Acuity - Low Illumination High Contrast
Description
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame
Baseline (after 5 minutes of lens dispense)
Title
Binocular Near Visual Acuity - Low Illumination High Contrast
Description
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Lens Fit - Post Blink Movement
Description
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame
Baseline (after 15 minutes of lens dispense)
Title
Lens Fit - Post Blink Movement
Description
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time Frame
2 weeks
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 15 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
2 weeks
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 15 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
2 weeks
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 15 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
2 weeks
Title
Subjective Ratings for Vision Quality - Distance Vision
Description
Patient subjective scoring using 0-100 continuous scale 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
Baseline (after 15 minutes of lens dispense)
Title
Subjective Ratings for Vision Quality - Distance Vision
Description
Patient subjective scoring using 0-100 continuous scale 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
2 weeks
Title
Subjective Ratings for Vision Quality - Near Vision
Description
Patient subjective scoring using 0-100 continuous scale 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
Baseline (after 15 minutes of lens dispense)
Title
Subjective Ratings for Vision Quality - Near Vision
Description
Patient subjective scoring using 0-100 continuous scale 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
2 weeks
Title
Subjective Ratings for Vision Quality - Computer Vision
Description
Patient subjective scoring using 0-100 continuous scale for Computer 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
Baseline (after 15 minutes of lens dispense)
Title
Subjective Ratings for Vision Quality - Computer Vision
Description
Patient subjective scoring using 0-100 continuous scale for Computer 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
2 weeks
Title
Subjective Ratings for Vision Quality - Overall Vision
Description
Patient subjective scoring using 0-100 continuous scale for Overall 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
Baseline (after 15 minutes of lens dispense)
Title
Subjective Ratings for Vision Quality - Overall Vision
Description
Patient subjective scoring using 0-100 continuous scale for Overall 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
2 weeks
Title
Corneal Staining Extent
Description
Corneal staining extent was assessed 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
2 weeks
Title
Conjunctival Staining
Description
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
Time Frame
2 weeks

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: 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 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: 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 Visual Acuity Is participating in any other type of eye related clinical or research study Has participated in study CV-14-32.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete Kollbaun, OD PhD
Organizational Affiliation
CORL Indiana University
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

Dispensing Study for the Phenacite Project

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