NCT02642991

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

December 7, 2015

Results QC Date

November 5, 2020

Last Update Submit

November 5, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (18)

  • 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 Outcomes (21)

  • Biomicroscopy Findings - Bulbar Hyperemia

    1 week

  • Biomicroscopy Findings- Limbal Hyperemia

    1 week

  • Biomicroscopy Findings - Corneal Staining Extent

    1 week

  • Ghosting - Distance Vision

    1 week

  • Ghosting - Near Vision

    1 week

  • +16 more secondary outcomes

Study Arms (2)

Phenacite Test lens then comfilcon A control lens

EXPERIMENTAL

Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.

Device: PhenaciteDevice: comfilcon A

Comfilcon A control lens then Phenacite test Lens

ACTIVE COMPARATOR

Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.

Device: PhenaciteDevice: comfilcon A

Interventions

PhenaciteDEVICE

contact lens

Comfilcon A control lens then Phenacite test LensPhenacite Test lens then comfilcon A control lens
comfilcon ADEVICE

contact lens

Comfilcon A control lens then Phenacite test LensPhenacite Test lens then comfilcon A control lens

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California

Berkeley, California, 94720, United States

Location

CORL, Indiana University

Bloomington, Indiana, 47405, United States

Location

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Paul Chamberlain
Organization
CooperVision, Inc.
PChamberlain@coopervision.com
925 730-6754

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 30, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

December 1, 2020

Results First Posted

December 1, 2020

Record last verified: 2020-11

Locations

US(2)CA(1)