Comparing the Performance of 1 Day Multifocal Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Lens B; Device: Habitual Lenses; Device: Lens A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04449263

EX-MKTG-109

Details and patient eligibility

About

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Full description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Enrollment: 60 patients

Sex: All

Ages: 42+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is at least 42 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, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
7. Has refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

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: Single Blind

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60 participants in 3 patient groups

Lens A (Test)

Experimental group

Description:

Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.

Treatment:

Device: Habitual Lenses

Device: Lens A

Device: Lens B

Lens B (Control)

Active Comparator group

Description:

Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.

Treatment:

Device: Habitual Lenses

Device: Lens A

Device: Lens B

Habitual Lenses

Active Comparator group

Description:

All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.

Treatment:

Device: Habitual Lenses