Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors; Astigmatism

Treatments: Device: Verofilcon A toric contact lenses; Device: Stenfilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039112

CLA306-E001

Details and patient eligibility

About

The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Full description

Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wear of 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.
• Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
• Current wear of spherical contact lenses.
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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64 participants in 2 patient groups

P1fA, then MyDay Toric

Other group

Description:

Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.

Treatment:

Device: Stenfilcon A toric contact lenses

Device: Verofilcon A toric contact lenses

MyDay Toric, then P1fA

Other group

Description:

Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality.

Treatment:

Device: Stenfilcon A toric contact lenses

Device: Verofilcon A toric contact lenses