Clinical Performance 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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-09-09

Brief Summary

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The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

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Detailed Description

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In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

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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LID022821, then AOHP

Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Group Type OTHER

Serafilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Senofilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

AOHP, then LID022821

Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit.

Group Type OTHER

Serafilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Senofilcon A contact lenses

Intervention Type DEVICE

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

CLEAR CARE

Intervention Type DEVICE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Interventions

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Serafilcon A contact lenses

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Intervention Type DEVICE

Senofilcon A contact lenses

Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection

Intervention Type DEVICE

CLEAR CARE

Hydrogen peroxide based contact lens cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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LID022821 ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS AOHP CLEAR CARE® Cleaning and Disinfecting Solution

Eligibility Criteria

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Inclusion Criteria

* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye.
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

* Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
* Habitual wear of AOHP contact lenses.
* Habitual wear of any daily disposable contact lenses.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No