NCT04201639

Brief Summary

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 13, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

December 13, 2019

Results QC Date

November 15, 2022

Last Update Submit

January 9, 2023

Conditions

Myopia

Outcome Measures

Primary Outcomes (39)

  • Subjective Comfort After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Dispense Visit (Day 0)

  • Subjective Dryness After Contact Lens Insertion

    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

    Dispense Visit (Day 0)

  • Subjective Rating of Clarity of Vision After Contact Lens Insertion

    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

    Dispense Visit (Day 0)

  • Subjective Comfort After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Dryness After Contact Lens Insertion

    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Rating of Clarity of Vision After Contact Lens Insertion

    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Comfort After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Dryness After Contact Lens Insertion

    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Rating of Clarity of Vision After Contact Lens Insertion

    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Comfort After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Dryness After Contact Lens Insertion

    Participants rate their dryness after insertion on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Rating of Clarity of Vision After Contact Lens Insertion

    Participants rate their clarity of vision after insertion on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Comfort After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Dryness After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Rating of Clarity of Vision After Contact Lens Insertion

    Participants rate their comfort after insertion on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Comfort With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their comfort after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Dryness With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their dryness after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Rating of Vision Clarity With Contact Lens Wear After 6 Hours of Digital Device Use

    Participants rate their vision clarity after 6 hours of digital device use on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Comfort at End of Day With Contact Lens Wear

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Dryness at End of Day With Contact Lens Wear

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear

    Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

    Day 1

  • Subjective Comfort at End of Day With Contact Lens Wear

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Dryness at End of Day With Contact Lens Wear

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear

    Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).

    Day 7

  • Subjective Comfort at End of Day With Contact Lens Wear

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Dryness at End of Day With Contact Lens Wear

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear

    Participants rate their end of day vision clarity on a scale from 0 (worst) to 100 (best).

    Day 10

  • Subjective Comfort at End of Day With Contact Lens Wear

    Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Dryness at End of Day With Contact Lens Wear

    Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

  • Subjective Rating of Vision Clarity at End of Day With Contact Lens Wear

    Participants rate their end of day rating of vision clarity on a scale from 0 (worst) to 100 (best).

    Followup visit (occurring at a single visit any day from Day 12-16)

Study Arms (1)

Refit

EXPERIMENTAL

Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.

Device: Verofilcon A contact lenses

Interventions

Verofilcon A contact lensesDEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Also known as: Precision1™
Refit

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);
  • Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;
  • Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;
  • Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;
  • Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;
  • Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

You may not qualify if:

  • Is participating in any concurrent clinical or research study;
  • Has any known active\* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Is aphakic;
  • Has undergone refractive error surgery;
  • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Limitations and Caveats

The study was affected by the COVID-19 pandemic, which resulted in a mandated site closure to limit the spread of COVID-19.

Results Point of Contact

Title
Jill Woods
Organization
Centre for Ocular Research and Education
jwoods@uwaterloo.ca
5198884567

Study Officials

  • Lyndon Jones, PhD, FCOptom

    Centre for Ocular Research & Education

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 17, 2019

Study Start

December 13, 2019

Primary Completion

September 27, 2021

Study Completion

September 27, 2021

Last Updated

January 26, 2023

Results First Posted

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)