Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Astigmatism; Ametropia
• Intervention / Treatment: Device: Verofilcon A toric contact lenses; Device: Etafilcon A toric contact lenses

Detailed Description

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90012
      • Alcon Investigator 8135
    • Oakland, California, United States, 94607
      • Alcon Investigator 8062
  • Florida
    • Orlando, Florida, United States, 32803
      • Alcon Investigator 6355
  • Illinois
    • Franklin Park, Illinois, United States, 60131
      • Alcon Investigator 6614
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Alcon Investigator 6645
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Alcon Investigator 3382
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigator 6353
    • Memphis, Tennessee, United States, 38119
      • Alcon Investigator 2786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
• Any spherical monovision and multifocal lens wearers.
• Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
• 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: P1fA, then AMfA; Verofilcon A toric contact lenses worn first, with etafilcon A toric 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 toric contact lenses; Soft contact lenses for optical correction of astigmatism; Other Names: PRECISION1™ for Astigmatism; P1fA; Device: Etafilcon A toric contact lenses; Soft contact lenses for optical correction of astigmatism; Other Names: 1-DAY ACUVUE MOIST® for ASTIGMATISM; AMfA
Other: AMfA, then P1fA; Etafilcon A toric contact lenses worn first, with verofilcon A toric 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 toric contact lenses; Soft contact lenses for optical correction of astigmatism; Other Names: PRECISION1™ for Astigmatism; P1fA; Device: Etafilcon A toric contact lenses; Soft contact lenses for optical correction of astigmatism; Other Names: 1-DAY ACUVUE MOIST® for ASTIGMATISM; AMfA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (-0/+3 days), each study lens type

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lenses; Disposable
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CLA306-P001

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