Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Delefilcon A contact lenses

Detailed Description

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Eye Center
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • The Eye Doctors, Inc.
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Oculus Research, Inc.
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Wyomissing Optometric Center
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
• Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Key Exclusion Criteria:

• Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
• Monovision contact lens wear;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAILIES TOTAL1; Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.	Device: Delefilcon A contact lenses; Daily disposable, silicone hydrogel spherical contact lenses; Other Names: DAILIES TOTAL1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance VA With Study Lenses at Week 1	Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.	Week 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Contact Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLU484-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