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

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: Lens A; Device: Lens B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04831515

EX-MKTG-122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Lens A

Experimental group

Description:

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.

Treatment:

Device: Lens B

Device: Lens A

Lens B

Active Comparator group

Description:

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.

Treatment:

Device: Lens B

Device: Lens A