Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia; Ametropia
• Intervention / Treatment: Device: Verofilcon A contact lenses; Device: Kalifilcon A contact lenses

Detailed Description

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigator 6565
    • Orlando, Florida, United States, 32803
      • Alcon Investigator 6355
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Alcon Investigator 6583
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigator 6313

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

Key Inclusion Criteria:

• Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
• 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.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous PRECISION1 or INFUSE contact lens wearer.
• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
• Routinely sleeps in contact lenses.
• 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 Infuse; Verofilcon A contact lenses worn first, with kalifilcon 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; Commercially available silicone hydrogel contact lenses for daily disposable wear; Other Names: PRECISION1™; Device: Kalifilcon A contact lenses; Commercially available silicone hydrogel contact lenses for daily disposable wear; Other Names: Bausch + Lomb INFUSE™
Other: Infuse, then Precision1; Kalifilcon 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; Commercially available silicone hydrogel contact lenses for daily disposable wear; Other Names: PRECISION1™; Device: Kalifilcon A contact lenses; Commercially available silicone hydrogel contact lenses for daily disposable wear; Other Names: Bausch + Lomb INFUSE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. No inferential testing was pre-specified for this endpoint.	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 20, 2021
• Primary Completion (Actual): September 9, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-E002

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