Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Alcon

Status: Enrolling

Conditions: Presbyopia

Treatments: Device: Senofilcon A multifocal contact lenses; Device: Serafilcon A multifocal contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06469242

CLM234-C001

Details and patient eligibility

About

The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Full description

Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Enrollment: 96 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Currently pregnant or lactating.
• History of amblyopia, strabismus, or binocular vision abnormalities.
• Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
• Monovision contact lens wearers and wearers of contact lens in one eye only.
• 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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96 participants in 2 patient groups

LID233309, then Oasys MF

Other group

Description:

Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Treatment:

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: Serafilcon A multifocal contact lenses

Device: Senofilcon A multifocal contact lenses

Oasys MF, then LID233309

Other group

Description:

Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 10 hours per day, each wear period \[14 days (-0/+2)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Treatment:

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: Serafilcon A multifocal contact lenses

Device: Senofilcon A multifocal contact lenses