Clinical Comparison of Two Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04865354

CLE383-P005

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Full description

Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Successful wearer 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.
• Possess spectacles and 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 one of the days (day prior to each week 1 visit).
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
• Any monovision and multifocal lens wearers.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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170 participants in 2 patient groups

PRECISION1, then Clariti 1-Day

Other group

Description:

Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.

Treatment:

Device: Somofilcon A contact lenses

Device: Verofilcon A contact lenses

Clariti 1-Day, then PRECISION1

Other group

Description:

Somofilcon 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) for 8 days in a daily disposable modality.

Treatment:

Device: Somofilcon A contact lenses

Device: Verofilcon A contact lenses