Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Lehfilcon A contact lenses; Device: Multi-purpose disinfection solution; Device: Comfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04055519

CLY935-C007

Details and patient eligibility

About

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Full description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Sign Informed Consent document.
• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition or disease or use of medication that contraindicates contact lens wear.
• Eye surgery, irregular cornea, eye injury as specified in the protocol.
• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
• Habitually wears Biofinity contact lenses.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

LID017569, then Biofinity

Other group

Description:

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Treatment:

Device: Multi-purpose disinfection solution

Device: Comfilcon A contact lenses

Device: Lehfilcon A contact lenses

Biofinity, then LID017569

Other group

Description:

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Treatment:

Device: Multi-purpose disinfection solution

Device: Comfilcon A contact lenses

Device: Lehfilcon A contact lenses