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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-06-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Refractive Errors Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID205255 Toric, then Biofinity Toric

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.

Group Type OTHER

Lehfilcon A toric contact lenses

Intervention Type DEVICE

FDA-cleared silicone hydrogel toric contact lenses used as indicated

Comfilcon A toric contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel toric contact lenses used as indicated

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Biofinity Toric, then LID205255 Toric

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.

Group Type OTHER

Lehfilcon A toric contact lenses

Intervention Type DEVICE

FDA-cleared silicone hydrogel toric contact lenses used as indicated

Comfilcon A toric contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel toric contact lenses used as indicated

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Interventions

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Lehfilcon A toric contact lenses

FDA-cleared silicone hydrogel toric contact lenses used as indicated

Intervention Type DEVICE

Comfilcon A toric contact lenses

Commercially available silicone hydrogel toric contact lenses used as indicated

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID205255 Toric Biofinity Toric CooperVision® Biofinity® Toric

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No