Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04980456

CLY935-C019

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses 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 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;
• Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study participation.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
• 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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257 participants in 2 patient groups

TOTAL30, then Biofinity

Other group

Description:

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A contact lenses

Device: Lehfilcon A contact lenses

Biofinity, then TOTAL30

Other group

Description:

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A contact lenses

Device: Lehfilcon A contact lenses