Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04178720

CLY935-C010

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Full description

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing 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.
• Habitually wearing Biofinity contact lenses.
• Monovision contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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119 participants in 2 patient groups

LID018869

Experimental group

Description:

Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Treatment:

Device: CLEAR CARE

Device: Lehfilcon A contact lenses

Biofinity

Active Comparator group

Description:

Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.

Treatment:

Device: Comfilcon A contact lenses

Device: CLEAR CARE