Evaluating Two Multifocal Daily Disposable Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Test Lens; Device: Control Lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05579886

EX-MKTG-140

Details and patient eligibility

About

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.

Full description

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Enrollment: 60 patients

Sex: All

Ages: 42+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A person was eligible for inclusion in the study if he/she:

1. Was at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Was willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Exclusion criteria

A person was excluded from the study if he/she:

1. Was participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Lens

Active Comparator group

Description:

All participants wore the Control Lens for 2 weeks (Period 1)

Treatment:

Device: Control Lens

Test Lens

Experimental group

Description:

All participants wore the Test Lens for 2 weeks (Period 2)

Treatment:

Device: Test Lens