The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Ametropia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05766787

CLL949-C024

Details and patient eligibility

About

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Full description

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-specific inclusion criteria may apply.

Exclusion criteria

• Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
• Habitual wear of AOHP contact lenses.
• Habitual wear of any daily disposable contact lenses.
• 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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190 participants in 2 patient groups

LID022821, then AOHP

Other group

Description:

Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: Serafilcon A contact lenses

Device: Senofilcon A contact lenses

Device: CLEAR CARE

AOHP, then LID022821

Other group

Description:

Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: Serafilcon A contact lenses

Device: Senofilcon A contact lenses

Device: CLEAR CARE