Clinical trial NCT05579886: Evaluating Two Multifocal Daily Disposable Contact Lenses
Official title: Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2022-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort Just After Lens Insertion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ocoee
country: United States
facility: Coan Eye Care & Optical Boutique
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
Study officials:
affiliation: Sacco Eye Group
name: Andrew Sacco
role: PRINCIPAL_INVESTIGATOR
affiliation: Kannarr Eye Care
name: Shane Kannarr
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates
name: Michael Cymbor
role: PRINCIPAL_INVESTIGATOR
affiliation: Coan Eye Care & Optical Boutique
name: Roxanne Achong-Coan
role: PRINCIPAL_INVESTIGATOR
References: