Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Refractive Errors Clinical Trial

Official title:

Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044948
• Other study ID #: CLU484-P003
• Status: Completed
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses
Daily disposable, silicone hydrogel spherical contact lenses

Locations

Country	Name	City	State
United States	The Eye Doctors, Inc.	Eden Prairie	Minnesota
United States	Oculus Research, Inc.	Garner	North Carolina
United States	ProCare Vision Center	Granville	Ohio
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	Wyomissing Optometric Center	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance VA with study lenses at Week 1	Visual acuity (VA) will be measured with study lenses on eye using letter charts. VA will be recorded in Snellen where 20/20 represents normal distance eyesight.	Week 1