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

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Comfilcon A contact lenses; Device: CLEAR CARE; Device: Lehfilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04476784

CLY935-C013

Details and patient eligibility

About

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Full description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or prior Biofinity contact lens wearer in the past 3 months;
• Monovision contact lens wearer;
• 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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66 participants in 2 patient groups

LID018869, 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 during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Lehfilcon A contact lenses

Device: Comfilcon A contact lenses

Biofinity, then LID018869

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 during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Lehfilcon A contact lenses

Device: Comfilcon A contact lenses