Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

NCT ID: NCT04404725

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2021-07-29

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.

Conditions

Astigmatism; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

comfilcon A then 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.

Group Type: EXPERIMENTAL

comfilcon A

Intervention Type: DEVICE

Subjects will be randomized to wear comfilcon A for one month.

Samfilcon A

Intervention Type: DEVICE

Subjects will be randomized to wear samfilcon A for one month.

samfilcon A then 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.

Group Type: ACTIVE_COMPARATOR

comfilcon A

Intervention Type: DEVICE

Subjects will be randomized to wear comfilcon A for one month.

Samfilcon A

Intervention Type: DEVICE

Subjects will be randomized to wear samfilcon A for one month.

Interventions

comfilcon A

Subjects will be randomized to wear comfilcon A for one month.

Intervention Type: DEVICE

Samfilcon A

Subjects will be randomized to wear samfilcon A for one month.

Intervention Type: DEVICE

Other Intervention Names

Biofinity Toric Multifocal; Ultra Multifocal for Astigmatism

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD FCOptom

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Fiona Soong

Role: PRINCIPAL_INVESTIGATOR

Eyes on Sheppard Clinic

Adam Keech

Role: PRINCIPAL_INVESTIGATOR

Oakley Eyecare

Howard Dolman

Role: PRINCIPAL_INVESTIGATOR

Dolman Eyecare Centre

Kristin Heeney

Role: PRINCIPAL_INVESTIGATOR

Spadina Optometry

Michael Kreuzer

Role: PRINCIPAL_INVESTIGATOR

Glasses Half Full

Shane Foster

Role: PRINCIPAL_INVESTIGATOR

Athens Eye Care

Michael Cymbor

Role: PRINCIPAL_INVESTIGATOR

Nittany Eye Associates

Locations

Athens Eye care

Athens, Ohio, United States

Nittany Eye Associates

State College, Pennsylvania, United States

Glasses Half Full

Edmonton, Alberta, Canada

Oakley Eyecare

Winnipeg, Manitoba, Canada

Dolman Eyecare Centre

New Hamburg, Ontario, Canada

Spadina Optometry

Toronto, Ontario, Canada

Lyndon Jones

Waterloo, Ontorio, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-110

Identifier Type: -

Identifier Source: org_study_id