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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Lens B	Lens A	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.
Lens B	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.
Lens A	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.
Lens A	Lens B	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.

Primary Outcome Measures

Name	Time	Method
Overall Ease of Lens Handling	1 week	Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	1 week	Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

Locations (4): Golden Optometric Group
🇺🇸
Whittier, California, United States
Sacco Eye Group
🇺🇸
Vestal, New York, United States
Athens Eye Care
🇺🇸
Athens, Ohio, United States
Golden Vision
🇺🇸
Sarasota, Florida, United States