Clinical Performance of Two Daily Disposable Soft Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05138783

CLE383-P006

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.

Full description

Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
• Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
• Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
• Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
• Monovision and multifocal lens wear.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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129 participants in 2 patient groups

PRECISION1, then Biotrue

Other group

Description:

Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Treatment:

Device: Nesofilcon A contact lenses

Device: Verofilcon A contact lenses

Biotrue, then PRECISION1

Other group

Description:

Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day.

Treatment:

Device: Nesofilcon A contact lenses

Device: Verofilcon A contact lenses