Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

Alcon

Status: Completed

Conditions: Astigmatism; Presbyopia

Treatments: Device: Samfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution; Device: Lehfilcon A multifocal for astigmatism contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06461455

CLR624-C001

Details and patient eligibility

About

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

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 30 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 5 office visits. The total duration of study participation is approximately 66 days.

Enrollment: 95 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
• Willing to not use readers while wearing study contact lenses for duration of the study;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• 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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95 participants in 2 patient groups

LID230451, then ULTRA MFfA

Other group

Description:

Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Treatment:

Device: Lehfilcon A multifocal for astigmatism contact lenses

Device: Lehfilcon A multifocal for astigmatism contact lenses

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: Samfilcon A multifocal for astigmatism contact lenses

ULTRA MFfA, then LID230451

Other group

Description:

Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period \[30 days (-2/+1)\]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.

Treatment:

Device: Lehfilcon A multifocal for astigmatism contact lenses

Device: Lehfilcon A multifocal for astigmatism contact lenses

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: CLEAR CARE® Cleaning & Disinfecting Solution

Device: Samfilcon A multifocal for astigmatism contact lenses