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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2019-12-03

Brief Summary

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The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

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Detailed Description

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Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LID017569, then Biofinity

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

Multi-purpose disinfection solution

Intervention Type DEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Biofinity, then LID017569

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Investigational silicone hydrogel contact lenses

Comfilcon A contact lenses

Intervention Type DEVICE

Commercially available silicone hydrogel contact lenses

Multi-purpose disinfection solution

Intervention Type DEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Interventions

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Lehfilcon A contact lenses

Investigational silicone hydrogel contact lenses

Intervention Type DEVICE

Comfilcon A contact lenses

Commercially available silicone hydrogel contact lenses

Intervention Type DEVICE

Multi-purpose disinfection solution

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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LID017569 Biofinity® OPTI-FREE® RepleniSH®

Eligibility Criteria

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Inclusion Criteria

* Sign Informed Consent document.
* Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.

Exclusion Criteria

* Any eye condition or disease or use of medication that contraindicates contact lens wear.
* Eye surgery, irregular cornea, eye injury as specified in the protocol.
* Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
* Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
* Habitually wears Biofinity contact lenses.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No