Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06044948

CLU484-P003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

DAILIES TOTAL1

Experimental group

Description:

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.

Treatment:

Device: Delefilcon A contact lenses