Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-07-02

Brief Summary

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The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

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Detailed Description

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This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Conditions

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Astigmatism

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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Lens A

daily disposable soft contact lens - test lens

Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

daily disposable soft contact lens - test lens

Lens B

Intervention Type DEVICE

daily disposable soft contact lens - control lens

Lens B

daily disposable soft contact lens - control lens

Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.

Group Type ACTIVE_COMPARATOR

Lens A

Intervention Type DEVICE

daily disposable soft contact lens - test lens

Lens B

Intervention Type DEVICE

daily disposable soft contact lens - control lens

Interventions

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Lens A

daily disposable soft contact lens - test lens

Intervention Type DEVICE

Lens B

daily disposable soft contact lens - control lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is at least 18 years of age 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;
* Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
* Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
* Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
* Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria

* Is participating in any concurrent clinical or research study;
* Habitually wears one of the study contact lenses;
* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes