Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses

Alcon

Status: Completed

Conditions: Astigmatism; Ametropia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06165627

CLV201-P003

Details and patient eligibility

About

The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.

Full description

Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days.

Enrollment: 67 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 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 0.10 logMAR in each eye;
• Willing and able to wear the study lenses as specified in the protocol;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
• Monovision and multifocal contact lens wearers;
• Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
• Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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67 participants in 2 patient groups

T30fA, then Biofinity Toric

Other group

Description:

Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A toric contact lenses

Device: Lehfilcon A toric contact lenses

Biofinity Toric, then T30fA

Other group

Description:

Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \[-1/+3\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \& Disinfecting Solution.

Treatment:

Device: CLEAR CARE

Device: Comfilcon A toric contact lenses

Device: Lehfilcon A toric contact lenses