Dispensing Study for a New Study Lens

Dispensing Study for The Phenacite Project

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Phenacite; Device: comfilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo
• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • CORL, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenacite Test lens then comfilcon A control lens; Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.	Device: Phenacite; contact lens; Device: comfilcon A; contact lens
Active Comparator: Comfilcon A control lens then Phenacite test Lens; Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.	Device: Phenacite; contact lens; Device: comfilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) - High Illumination	Distance visual acuity High Illumination was assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - High Illumination	Distance visual acuity High Illumination was assessed using logMAR	1 week
Near Visual Acuity (VA) - High Illumination	Near Visual Acuity (VA) - High Illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - High Illumination	Near Visual Acuity (VA) - High Illumination assessed using logMAR	1 week
Distance Visual Acuity (VA) - Low Illumination	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - Low Illumination	Distance Visual Acuity (VA) - Low Illumination assessed using logMAR	1 week
Near Visual Acuity (VA) - Low Illumination	Near Visual Acuity (VA) - Low illumination assessed using logMAR	Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - Low Illumination	Near Visual Acuity (VA) - Low illumination assessed using logMAR	1 week
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)	Baseline (after 10 minutes of lens dispense)
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)	1 week
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	Baseline (After 10 minutes of lens dispense)
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	1 week
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)	Baseline (After 10 minutes of lens dispense)
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)	1 week
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)	Baseline (After 10 minutes of lens dispense)
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)	1 week
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)	Baseline (After 10 minutes of lens dispense)
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)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 week
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)	1 week
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	1 week
Ghosting - Distance Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	1 week
Ghosting - Near Vision	Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable	1 week
Overall Comfort	Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	Baseline (After 10 minutes of lens dispense)
Overall Comfort	Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.	1 week
Overall Dryness	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	Baseline (after 10 minutes of lens dispense)
Overall Dryness	Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.	1 week
Lens Preference - Overall Vision Preference	Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)	1 week
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)	1 week
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)	1 week
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)	1 week
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)	1 week
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)	1 week
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)	1 week
Subjective Questionnaire Response - Eye Strain	Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree	1 week
Subjective Questionnaire Response - Eye Feel Good	Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree	1 week
Subjective Questionnaire Response - Eye Feel Relaxed	Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree	1 week
Subjective Questionnaire Response - Vision	Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree	1 week
Subjective Questionnaire Response - Eye Tired	Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree	1 week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, CCLR, University of Waterloo; Principal Investigator: Pete Kollbaum, OD, PhD, CORL, Indiana University; Principal Investigator: Meng Lin, OD, PhD, CRC, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-15-41

Drug and device information, study documents

• 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