Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Alcon

Status: Completed

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 wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of lens wear.

Enrollment: 106 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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106 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 in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

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 in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: Serafilcon A multifocal contact lenses

Device: Senofilcon A multifocal contact lenses