Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Study Overview

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

Detailed Description

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Alcon Investigator 6402
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigator 6313
  • Texas
    • Wichita Falls, Texas, United States, 76308
      • Alcon Investigator 8028

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular condition that contraindicates contact lens wear.
• Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
• Other protocol-specified 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 ONEday; 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) for 8 -0/+3 days in a daily disposable modality.	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; Bausch + Lomb Biotrue® ONEday
Other: Biotrue ONEday, 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) for 8 -0/+3 days in a daily disposable modality.	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; Bausch + Lomb Biotrue® ONEday

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) With Study Lenses	Distance 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. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.	Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: CDMA Project Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Daily disposable contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-P003

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