Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

NCT04404725 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-110
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Astigmatism; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Ease of Lens Handling at Insertion

  Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).

  Day 28

Study Arms (2)

comfilcon A then samfilcon A

EXPERIMENTAL

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

Device: comfilcon A; Device: Samfilcon A

samfilcon A then comfilcon A

ACTIVE COMPARATOR

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

Device: comfilcon A; Device: Samfilcon A

Interventions

comfilcon A DEVICE

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

Also known as: Biofinity Toric Multifocal

comfilcon A then samfilcon A; samfilcon A then comfilcon A

Samfilcon A DEVICE

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

Also known as: Ultra Multifocal for Astigmatism

comfilcon A then samfilcon A; samfilcon A then comfilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 42 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Self reports having a full eye examination in the previous two years;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears soft contact lens for the past 3 months minimum;
• Has refractive astigmatism of at least -0.75DC;
• Is presbyopic and requires a reading addition of at least +0.75D;
• 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).

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Habitually wears one of the study contact lenses;
• Has any known active\* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
• Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (7)

Athens Eye care

Athens, Ohio, 45701, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

Glasses Half Full

Edmonton, Alberta, T5N1S5, Canada

Location

Oakley Eyecare

Winnipeg, Manitoba, R2C 3B4, Canada

Location

Dolman Eyecare Centre

New Hamburg, Ontario, N3A 1K2, Canada

Location

Spadina Optometry

Toronto, Ontario, M5V 2K8, Canada

Location

Lyndon Jones

Waterloo, Ontorio, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, OD, MSc, FAAO
• Organization: CooperVision, Inc

JVega2@coopervision.com

9256213761

Study Officials

• Lyndon Jones, PhD FCOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Fiona Soong

  Eyes on Sheppard Clinic

  PRINCIPAL INVESTIGATOR

• Adam Keech

  Oakley Eyecare

  PRINCIPAL INVESTIGATOR

• Howard Dolman

  Dolman Eyecare Centre

  PRINCIPAL INVESTIGATOR

• Kristin Heeney

  Spadina Optometry

  PRINCIPAL INVESTIGATOR

• Michael Kreuzer

  Glasses Half Full

  PRINCIPAL INVESTIGATOR

• Shane Foster

  Athens Eye Care

  PRINCIPAL INVESTIGATOR

• Michael Cymbor

  Nittany Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: August 6, 2020
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-02

Locations

US (2); CA (5)