Clinical Evaluation of a Manufacturing Process for a Frequent Replacement Silicone Hydrogel Multifocal Contact Lens

Alcon

Status: Completed

Conditions: Refractive Ametropia

Treatments: Device: Lotrafilcon B multifocal contact lenses; Device: Lehfilcon A multifocal contact lenses; Device: Hydrogen peroxide-based cleaning and disinfection system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05765227

CLN705-M103

Details and patient eligibility

About

The purpose of this clinical trial was to evaluate the clinical performance of a manufacturing process on a frequent replacement multifocal contact lens.

Full description

Subjects will be expected to attend 3 scheduled visits. Eligible subjects will wear each study lens type in a cross-over fashion for approximately 2 days.

Enrollment: 18 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an consent form (ICF) that has been approved by an Institutional Review Board (IRB);
• Willing to stop wearing habitual contact lenses for the duration of study participation;
• Currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Other protocol-defined inclusion criteria may apply.

Key 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 refractive surgery, or plan to have refractive surgery during the study;
• Current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator;
• Monovision contact lens wear;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

LID#224381, then AOHG MF

Other group

Description:

Lehfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: Hydrogen peroxide-based cleaning and disinfection system

Device: Lehfilcon A multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses

AOHG MF, then LID#224381

Other group

Description:

Lotrafilcon B multifocal contact lenses worn first, with lehfilcon A multifocal contact lenses worn second in pre-determined order. Each study lens type will be worn bilaterally (in both eyes) for approximately 2 days. CLEAR CARE will be used for nightly cleaning and disinfection.

Treatment:

Device: Hydrogen peroxide-based cleaning and disinfection system

Device: Lehfilcon A multifocal contact lenses

Device: Lotrafilcon B multifocal contact lenses