Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens

Alcon

Status: Completed

Conditions: Refractive Errors; Astigmatism

Treatments: Device: CLEAR CARE; Device: Comfilcon A toric contact lenses; Device: Lehfilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05211739

CLV201-C002

Details and patient eligibility

About

The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.

Full description

Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wearers of weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months;
• Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
• Able to wear contact lenses within the range of available sphere & cylinder power and axes.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Daily disposable contact lens wearers.
• Monovision and multifocal contact lens wearers.
• Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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76 participants in 2 patient groups

LID205255 Toric, then Biofinity Toric

Other group

Description:

Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Treatment:

Device: Lehfilcon A toric contact lenses

Device: Comfilcon A toric contact lenses

Device: CLEAR CARE

Biofinity Toric, then LID205255 Toric

Other group

Description:

Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Treatment:

Device: Lehfilcon A toric contact lenses

Device: Comfilcon A toric contact lenses

Device: CLEAR CARE