Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses

Alcon

Status: Completed

Conditions: Presbyopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05702541

CLN705-M102

Details and patient eligibility

About

The purpose of this clinical trial is to assess the clinical performance of LID223194 Multifocal (MF) contact lenses and commercially available Air Optix plus HydraGlyde (AOHG) MF contact lenses. Eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

Full description

Subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Enrollment: 16 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: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

16 participants in 2 patient groups

LID223194 MF, then AOHG MF

Other group

Description:

Lehfilcon A multifocal contact lenses worn first, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: Lotrafilcon B multifocal contact lenses

Device: Hydrogen peroxide-based cleaning and disinfection system

Device: Lehfilcon A multifocal contact lenses

AOHG MF, then LID223194 MF

Other group

Description:

Lotrafilcon B multifocal contact lenses worn first, followed by lehfilcon A multifocal contact lenses, as randomized. Each product will be worn in both eyes for 2 days in a daily wear modality. CLEAR CARE will be used for daily cleaning and disinfection.

Treatment:

Device: Lotrafilcon B multifocal contact lenses

Device: Hydrogen peroxide-based cleaning and disinfection system

Device: Lehfilcon A multifocal contact lenses