Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05431478

CLL949-E005

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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Enrollment: 68 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 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 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-specified inclusion criteria may apply.

Key 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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68 participants in 2 patient groups

LID022821, then AOHP

Other group

Description:

Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Treatment:

Device: CLEAR CARE

Device: Senofilcon A contact lenses

Device: Serafilcon A contact lenses

AOHP, then LID022821

Other group

Description:

Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Treatment:

Device: CLEAR CARE

Device: Senofilcon A contact lenses

Device: Serafilcon A contact lenses