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

Alcon

Status: Completed

Conditions: Refractive Errors; Astigmatism; Presbyopia

Treatments: Device: Lehfilcon A multifocal toric contact lenses; Device: Samfilcon A multifocal toric contact lenses; Device: CLEAR CARE

Study type: Interventional

Funder types: Industry

Identifiers

NCT05886907

CLR624-M103

Details and patient eligibility

About

The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Full description

Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Enrollment: 18 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Requires ADD (additional power for near vision);
• Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
• Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
• Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any anterior segment 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;
• Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
• Monovision contact lens wear.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

18 participants in 2 patient groups

LID223188, then Ultra MFT

Other group

Description:

Lehfilcon A multifocal toric contact lenses worn first, with samfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Samfilcon A multifocal toric contact lenses

Device: Lehfilcon A multifocal toric contact lenses

Ultra MFT, then LID223188

Other group

Description:

Samfilcon A multifocal toric contact lenses worn first, with lehfilcon A multifocal toric contact lenses worn second. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 2 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Treatment:

Device: CLEAR CARE

Device: Samfilcon A multifocal toric contact lenses

Device: Lehfilcon A multifocal toric contact lenses