Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

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

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2022-02-22

Brief Summary

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The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

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Detailed Description

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Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

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

DOUBLE

Participants Investigators

Study Groups

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LID018869, then AOHP

Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Senofilcon A contact lenses

Intervention Type DEVICE

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

AOHP, then LID018869

Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Senofilcon A contact lenses

Intervention Type DEVICE

Commercially available, silicone hydrogel, spherical 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 contact lenses

Commercially available, silicone hydrogel, spherical contact lenses used as indicated

Intervention Type DEVICE

Senofilcon A contact lenses

Commercially available, silicone hydrogel, spherical 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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LID018869 AOHP

Eligibility Criteria

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Inclusion Criteria

* Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Manifest cylinder less than or equal to 0.75 diopter in each eye.
* Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.

Exclusion Criteria

* Monovision or multifocal lens wearer.
* Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
* Routinely sleeps in habitual contact lenses.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No