Performance Evaluation of Different Daily Disposable 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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2023-06-20

Brief Summary

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

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Detailed Description

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This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving 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 Contact Lens, Then Test Contact Lens

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

Group Type EXPERIMENTAL

Control Contact Lens (stenfilcon A)

Intervention Type DEVICE

one week wear

Test Contact Lens (senofilcon A)

Intervention Type DEVICE

one week of wear

Test Contact Lens, Then Control Contact Lens

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

Group Type EXPERIMENTAL

Control Contact Lens (stenfilcon A)

Intervention Type DEVICE

one week wear

Test Contact Lens (senofilcon A)

Intervention Type DEVICE

one week of wear

Interventions

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Control Contact Lens (stenfilcon A)

one week wear

Intervention Type DEVICE

Test Contact Lens (senofilcon A)

one week of wear

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. 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.
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes