NCT04865354

Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 6, 2022

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

April 26, 2021

Results QC Date

June 9, 2022

Last Update Submit

June 9, 2022

Conditions

Refractive Errors

Keywords

Contact LensesDisposable

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Distance VA (logMAR) With Study Lenses

    Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

    Day 8, each study lens type

Study Arms (2)

PRECISION1, then Clariti 1-Day

OTHER

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.

Device: Verofilcon A contact lensesDevice: Somofilcon A contact lenses

Clariti 1-Day, then PRECISION1

OTHER

Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.

Device: Verofilcon A contact lensesDevice: Somofilcon A contact lenses

Interventions

Verofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: PRECISION1
Clariti 1-Day, then PRECISION1PRECISION1, then Clariti 1-Day
Somofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: Clariti 1-Day
Clariti 1-Day, then PRECISION1PRECISION1, then Clariti 1-Day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
  • Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
  • Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).

You may not qualify if:

  • Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
  • Any monovision and multifocal lens wearers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Alcon Investigator 8106

San Francisco, California, 94127, United States

Location

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6418

Tallahassee, Florida, 32308, United States

Location

Alcon Investigator 6614

Franklin Park, Illinois, 60131, United States

Location

Alcon Investigator 6645

Shawnee Mission, Kansas, 66204, United States

Location

Alcon Investigator 6402

Medina, Minnesota, 55340, United States

Location

Alcon Investigator 8046

Granville, Ohio, 43023, United States

Location

Alcon Investigator 8028

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Sr. Project Lead, CDMA Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • CDMA Clinical Trial Lead, Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

April 26, 2021

First Posted

April 29, 2021

Study Start

May 17, 2021

Primary Completion

June 27, 2021

Study Completion

June 27, 2021

Last Updated

July 6, 2022

Results First Posted

July 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(8)