Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Not Applicable

Completed

• Conditions: Presbyopia; Astigmatism
• Interventions: Device: comfilcon A; Device: Samfilcon A

• Registration Number: NCT04404725
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Study Start: 2020-08-06
• Primary Completion: 2021-07-29
• Study Completion: 2021-07-29
• Results First Submitted: 2022-01-20
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
samfilcon A then comfilcon A	comfilcon A	Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A then samfilcon A	Samfilcon A	Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
comfilcon A then samfilcon A	comfilcon A	Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study.
samfilcon A then comfilcon A	Samfilcon A	Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study.

Primary Outcome Measures

Name	Time	Method
Ease of Lens Handling at Insertion	Day 28	Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).

Trial Locations

Locations (7)

Glasses Half Full; 🇨🇦 Edmonton, Alberta, Canada

Athens Eye care; 🇺🇸 Athens, Ohio, United States

Nittany Eye Associates; 🇺🇸 State College, Pennsylvania, United States

Oakley Eyecare; 🇨🇦 Winnipeg, Manitoba, Canada

Dolman Eyecare Centre; 🇨🇦 New Hamburg, Ontario, Canada

Lyndon Jones; 🇨🇦 Waterloo, Ontorio, Canada

Spadina Optometry; 🇨🇦 Toronto, Ontario, Canada