NCT05138783

Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

November 15, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

November 15, 2021

Results QC Date

March 6, 2023

Last Update Submit

March 29, 2023

Conditions

Refractive Errors

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Distance Visual Acuity (VA) With Study Lenses

    Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

    Day 8 (-0/+3 days), each study lens type

Study Arms (2)

PRECISION1, then Biotrue

OTHER

Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Device: Verofilcon A contact lensesDevice: Nesofilcon A contact lenses

Biotrue, then PRECISION1

OTHER

Nesofilcon 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) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Device: Verofilcon A contact lensesDevice: Nesofilcon A contact lenses

Interventions

Verofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: PRECISION1™
Biotrue, then PRECISION1PRECISION1, then Biotrue
Nesofilcon A contact lensesDEVICE

Spherical soft contact lenses for daily disposable wear

Also known as: Biotrue® ONEday
Biotrue, then PRECISION1PRECISION1, then Biotrue

Eligibility Criteria

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

You may qualify if:

  • Successful wear 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.
  • 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 the day prior to Visit 2 and the day prior to Visit 3.

You may not qualify if:

  • Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
  • Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
  • Monovision and multifocal lens wear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Kindred Optics at Maitland Vision

Maitland, Florida, 32751, United States

Location

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

Franklin Park Eye Center PC

Franklin Park, Illinois, 60131, United States

Location

Heart of America Eye Care

Shawnee Mission, Kansas, 66204, United States

Location

Complete Eye Care Of Medina

Medina, Minnesota, 55340, United States

Location

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

Location

Clarke EyeCare Center

Wichita Falls, Texas, 76308, United States

Location

Stine Eye Center

Weston, Wisconsin, 54476, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

Study Officials

  • 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

November 15, 2021

First Posted

December 1, 2021

Study Start

January 12, 2022

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

April 18, 2023

Results First Posted

April 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(8)