Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

Coopervision, Inc.5 sites in 1 country60 target enrollmentOctober 10, 2022

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: Coopervision, Inc.
Enrollment: 60
Locations: 5
Primary Endpoint: Comfort Just After Lens Insertion
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 10, 2022

End Date

February 7, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A person was eligible for inclusion in the study if he/she:
•Was at least 42 years of age and had full legal capacity to volunteer;
•Had read and signed an information consent letter;
•Self-reported having had a full eye examination in the previous two years;
•Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
•Was willing and able to follow instructions and maintain the appointment schedule;
•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);
•Had refractive astigmatism no higher than -0.75DC in each eye;
•Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
•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:
•Was participating in any concurrent clinical or research study;
•Had any known active ocular disease and/or infection that contraindicated contact lens wear;
•Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
•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;
•Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
•Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
•Had undergone refractive error surgery or interocular surgery.