Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Alcon

Status: Completed

Conditions: Refractive Ametropia

Treatments: Device: LID015385 soft contact lenses; Device: Comfilcon A soft contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085328

CLL949-C010

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Full description

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Enrollment: 675 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign an Informed Consent Form.
• Willing to attend all scheduled study visits as required per protocol.
• Willing and able to wear assigned study lenses as required per protocol.
• Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
• History of eye surgery, including refractive surgery.
• Currently pregnant or breast-feeding.
• Monovision contact lens wearers.
• Daily disposable 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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675 participants in 2 patient groups

LID015385

Experimental group

Description:

LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Treatment:

Device: LID015385 soft contact lenses

Biofinity

Active Comparator group

Description:

Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Treatment:

Device: Comfilcon A soft contact lenses