Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Device: LID220365 contact lens; Device: LID006961 contact lens

Detailed Description

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Kindred Optics at Maitland Vision
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Illinois
    • Franklin Park, Illinois, United States, 60131
      • Franklin Park Eye Center PC
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry Clinical Vision Research Center
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Wyomissing Optometric Center
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
  • Texas
    • Wichita Falls, Texas, United States, 76308
      • Clarke EyeCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
• Habitual monovision or multifocal contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID220365 (OD) / LID006961 (OS); LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.	Device: LID220365 contact lens; Investigational delefilcon A spherical contact lens made with a modified manufacturing process; Device: LID006961 contact lens; Commercially available delefilcon A spherical contact lens; Other Names: DAILIES TOTAL1®
Other: LID006961 (OD) / LID220365 (OS); LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.	Device: LID220365 contact lens; Investigational delefilcon A spherical contact lens made with a modified manufacturing process; Device: LID006961 contact lens; Commercially available delefilcon A spherical contact lens; Other Names: DAILIES TOTAL1®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4	VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.	Day 4

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLX679-C001

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