Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors; Hyperopia

Treatments: Device: CLEAR CARE; Device: Comfilcon A contact lenses; Device: LID015385 contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04207749

CLL949-C018

Details and patient eligibility

About

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

Full description

Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
• Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
• Best spectacle corrected visual acuity 20/20 or better in each eye.
• Other protocol-defined 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.
• Monovision contact lens wear.
• Any habitual wear of Biofinity lenses.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 2 patient groups

LID015385

Experimental group

Description:

LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: LID015385 contact lenses

Device: CLEAR CARE

Biofinity

Active Comparator group

Description:

Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: Comfilcon A contact lenses

Device: CLEAR CARE