Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors; Hyperopia

Treatments: Device: Comfilcon A contact lens; Device: Lehfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT04403542

CLY935-C008

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Full description

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an IRB/IEC approved Informed Consent form.
• Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
• Best corrected visual acuity of 20/25 or better in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
• Any habitual wear of Biofinity contact lenses.
• Pregnant or breast-feeding.
• 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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36 participants in 2 patient groups

LID018869 (OD) / Biofinity (OS)

Experimental group

Description:

Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Treatment:

Device: Lehfilcon A contact lens

Device: Comfilcon A contact lens

Biofinity (OD) / LID018869 (OS)

Active Comparator group

Description:

Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Treatment:

Device: Lehfilcon A contact lens

Device: Comfilcon A contact lens