Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

NCT06044948 | Completed Results FDA Device

• 1 other identifier: CLU484-P003
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Refractive Errors

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DAILIES TOTAL1

EXPERIMENTAL

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

Interventions

Delefilcon A contact lenses DEVICE

Daily disposable, silicone hydrogel spherical contact lenses

Also known as: DAILIES TOTAL1

DAILIES TOTAL1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (6)

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

The Eye Doctors, Inc.

Eden Prairie, Minnesota, 55344, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

8884513937

Study Officials

• Clinical Trial Lead, CRD Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In this single arm study, the subject will be masked to the lens type.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 13, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)