Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Lehfilcon A contact lenses; Device: CLEAR CARE; Device: Senofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05050578

CLY935-C022

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Full description

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Current wearer of a commercial spherical weekly/monthly soft contact lenses 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 in each eye.
• Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Monovision or multifocal lens wearer.
• Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
• Routinely sleeps in habitual contact lenses.
• 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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166 participants in 2 patient groups

LID018869, then AOHP

Other group

Description:

Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Treatment:

Device: Senofilcon A contact lenses

Device: CLEAR CARE

Device: Lehfilcon A contact lenses

AOHP, then LID018869

Other group

Description:

Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Treatment:

Device: Senofilcon A contact lenses

Device: CLEAR CARE

Device: Lehfilcon A contact lenses