Clinical Performance of a Silicone Hydrogel Contact Lens Following One Night of Extended Wear

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Comfilcon A contact lens; Device: LID011121 contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03560141

CLL949-C004

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 following 1 night of extended wear.

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 4 scheduled study visits. The lenses will be worn continuously from the time of dispense on Day 1 until lens collection at the Day 2 Follow-up/Exit Visit.

Enrollment: 12 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.
• Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality.
• Best Corrected Visual Acuity (BCVA) 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.
• Current Biofinity® lens wearer.
• Pregnant or breast-feeding.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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12 participants in 2 patient groups

LID011121 (OD) / Biofinity (OS)

Other group

Description:

LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear.

Treatment:

Device: LID011121 contact lens

Device: Comfilcon A contact lens

Biofinity (OD) / LID011121 (OS)

Other group

Description:

Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for one night of extended (overnight) wear.

Treatment:

Device: LID011121 contact lens

Device: Comfilcon A contact lens