Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Alcon

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lotrafilcon B multifocal contact lenses; Device: CLEAR CARE®; Device: Lehfilcon A multifocal contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05338333

CLN705-C001

Details and patient eligibility

About

The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.

Full description

Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Enrollment: 101 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
• Willing and able to attend all study visits as required by the protocol.
• Willing to stop wearing habitual contact lenses for the duration of the study.
• Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye infection, inflammation, 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 refractive surgery or planning to have refractive surgery during the study.
• Current or history of pathologically dry eye.
• Currently pregnant or lactating.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

101 participants in 2 patient groups

LID210464, then AOHG MF

Other group

Description:

Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Treatment:

Device: Lehfilcon A multifocal contact lenses

Device: CLEAR CARE®

Device: Lotrafilcon B multifocal contact lenses

AOHG MF, then LID210464

Other group

Description:

Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.

Treatment:

Device: Lehfilcon A multifocal contact lenses

Device: CLEAR CARE®

Device: Lotrafilcon B multifocal contact lenses