Clinical trial NCT04404725: Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Official title: Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 64
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Detailed description: The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.

Eligibility criteria: 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 soft contact lens for the past 3 months minimum;
7. Has refractive astigmatism of at least -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D;
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; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).

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;
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 and/or the care product Opti-Free PureMoist being 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. \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Primary outcomes:
measure: Ease of Lens Handling at Insertion
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Eye care
state: Ohio
city: State College
country: United States
facility: Nittany Eye Associates
state: Pennsylvania
city: Edmonton
country: Canada
facility: Glasses Half Full
state: Alberta
city: Winnipeg
country: Canada
facility: Oakley Eyecare
state: Manitoba
city: New Hamburg
country: Canada
facility: Dolman Eyecare Centre
state: Ontario
city: Toronto
country: Canada
facility: Spadina Optometry
state: Ontario
city: Waterloo
country: Canada
facility: Lyndon Jones
state: Ontorio
Study officials:
affiliation: University of Waterloo
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
affiliation: Eyes on Sheppard Clinic
name: Fiona Soong
role: PRINCIPAL_INVESTIGATOR
affiliation: Oakley Eyecare
name: Adam Keech
role: PRINCIPAL_INVESTIGATOR
affiliation: Dolman Eyecare Centre
name: Howard Dolman
role: PRINCIPAL_INVESTIGATOR
affiliation: Spadina Optometry
name: Kristin Heeney
role: PRINCIPAL_INVESTIGATOR
affiliation: Glasses Half Full
name: Michael Kreuzer
role: PRINCIPAL_INVESTIGATOR
affiliation: Athens Eye Care
name: Shane Foster
role: PRINCIPAL_INVESTIGATOR
affiliation: Nittany Eye Associates
name: Michael Cymbor
role: PRINCIPAL_INVESTIGATOR
References: