Two Daily Disposable Contact Lenses in Symptomatic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2018-09-25

Brief Summary

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The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOTAL1

Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality

Group Type EXPERIMENTAL

Delefilcon A contact lenses

Intervention Type DEVICE

Water Gradient silicon hydrogel daily disposable contact lenses

1-DAY

Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality

Group Type ACTIVE_COMPARATOR

Senofilcon A contact lenses

Intervention Type DEVICE

Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Interventions

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Delefilcon A contact lenses

Water Gradient silicon hydrogel daily disposable contact lenses

Intervention Type DEVICE

Senofilcon A contact lenses

Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology

Intervention Type DEVICE

Other Intervention Names

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DAILIES TOTAL1® (DT1) ACUVUE OASYS® 1-DAY

Eligibility Criteria

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Inclusion Criteria

* Able to understand and must sign an IRB-approved informed consent form;
* Soft contact lens wearers in both eyes during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

* Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
* Intolerance, hypersensitivity, or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monocular (only one eye with functional vision).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No