Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-06-01

Brief Summary

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The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

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Detailed Description

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This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

Conditions

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Myopia

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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Control Lens, Then Test Lens

Participants will wear control lenses for one week and then crossover to test lenses for one week.

Group Type EXPERIMENTAL

Control Lens (stenfilcon A)

Intervention Type DEVICE

One week wear

Test Lens (senofilcon A)

Intervention Type DEVICE

One week wear

Test Lens, Then Control Lens

Participants will wear test lenses for one week and then crossover to control lenses for one week.

Group Type EXPERIMENTAL

Control Lens (stenfilcon A)

Intervention Type DEVICE

One week wear

Test Lens (senofilcon A)

Intervention Type DEVICE

One week wear

Interventions

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Control Lens (stenfilcon A)

One week wear

Intervention Type DEVICE

Test Lens (senofilcon A)

One week wear

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Self-reports having a full eye examination in the previous two years;
* Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
* Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears soft contact lenses, for the past 3 months minimum;

1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
* Has refractive astigmatism no higher than -0.75DC in each eye;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection that contraindicates contact lens wear;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
* Has known sensitivity to the diagnostic sodium fluorescein used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery or intraocular surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No