Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

Study Results

Results available

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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

2022-01-12

Study Completion Date

2022-06-14

Brief Summary

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The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

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Detailed Description

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Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

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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TOTAL30, then AOHP

Lehfilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. The lehfilcon A contact lenses will be worn for approximately 28 days. The senofilcon A contact lenses will be worn for approximately 14 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

Senofilcon A contact lenses

Intervention Type DEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

AOSEPT PLUS with HydraGlyde

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

AOHP, then TOTAL30

Senofilcon A contact lenses worn first, with lehfilcon A contact lenses worn second, as randomized. The senofilcon A contact lenses will be worn for approximately 14 days. The lehfilcon A contact lenses will be worn for approximately 28 days. Lenses will be worn bilaterally (in both eyes) in a daily wear modality, with AOSEPT PLUS with HydraGlyde used for nightly cleaning and disinfection.

Group Type OTHER

Lehfilcon A contact lenses

Intervention Type DEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

Senofilcon A contact lenses

Intervention Type DEVICE

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

AOSEPT PLUS with HydraGlyde

Intervention Type DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Interventions

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Lehfilcon A contact lenses

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

Intervention Type DEVICE

Senofilcon A contact lenses

CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use

Intervention Type DEVICE

AOSEPT PLUS with HydraGlyde

Hydrogen peroxide-based cleaning and disinfecting solution

Intervention Type DEVICE

Other Intervention Names

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TOTAL30® ACUVUE OASYS® with HYDRACLEAR® Plus AOHP AOSEPT® PLUS with HYDRAGLYDE®

Eligibility Criteria

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Inclusion Criteria

* Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
* Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
* Willing to NOT use rewetting/lubricating drops at any time during the study.

Exclusion Criteria

* Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
* Habitual AOHP contact lens wearers (in the past 3 months).
* Monovision wear during the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No