Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04668989

EX-MKTG-118

Details and patient eligibility

About

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Full description

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is at least 18 years of age 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;
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. Habitually wears one of the study contact lenses;
3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
8. 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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68 participants in 2 patient groups

stenfilcon A - (Test lens)

Experimental group

Description:

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

Treatment:

Device: stenfilcon A - (Test lens)

Device: kalifilcon A - (Control Lens)

kalifilcon A - (Control Lens)

Active Comparator group

Description:

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

Treatment:

Device: stenfilcon A - (Test lens)

Device: kalifilcon A - (Control Lens)