Clinical Performance of Two Daily Disposable Soft Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses

Detailed Description

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Kindred Optics at Maitland Vision
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Eye Center
  • Illinois
    • Franklin Park, Illinois, United States, 60131
      • Franklin Park Eye Center PC
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Heart of America Eye Care
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers, Inc.
  • Texas
    • Wichita Falls, Texas, United States, 76308
      • Clarke EyeCare Center
  • Wisconsin
    • Weston, Wisconsin, United States, 54476
      • Stine Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• 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.
• Other protocol-defined exclusion criteria may apply.

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
Other: PRECISION1, then Biotrue; 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 lenses; Spherical soft contact lenses for daily disposable wear; Other Names: PRECISION1™; Device: Nesofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: Biotrue® ONEday
Other: Biotrue, then PRECISION1; 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 lenses; Spherical soft contact lenses for daily disposable wear; Other Names: PRECISION1™; Device: Nesofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: Biotrue® ONEday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 7, 2022

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-P006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No