Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920280

CLL949-C009

Details and patient eligibility

About

The purpose of this clinical study is to demonstrate 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.

Full description

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Enrollment: 120 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 ≤ 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.
• Monovision contact lens wearers.
• Habitually wearing Biofinity® lenses.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

LID015385

Experimental group

Description:

LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Treatment:

Device: LID015385 contact lenses

Device: CLEAR CARE

Biofinity

Active Comparator group

Description:

Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A soft contact lenses