Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

February 9, 2022 updated by: Coopervision, Inc.
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5N1S5
        • Glasses Half Full
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2C 3B4
        • Oakley Eyecare
    • Ontario
      • New Hamburg, Ontario, Canada, N3A 1K2
        • Dolman Eyecare Centre
      • Toronto, Ontario, Canada, M5V 2K8
        • Spadina Optometry
    • Ontorio
      • Waterloo, Ontorio, Canada, N2L 3G1
        • Lyndon Jones
  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Athens Eye Care
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Nittany Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: comfilcon A
Subjects will be randomized to wear comfilcon A for one month.
Other Names:
  • Biofinity Toric Multifocal
Device: Samfilcon A
Subjects will be randomized to wear samfilcon A for one month.
Other Names:
  • Ultra Multifocal for Astigmatism
Active Comparator: 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.
Device: comfilcon A
Subjects will be randomized to wear comfilcon A for one month.
Other Names:
  • Biofinity Toric Multifocal
Device: Samfilcon A
Subjects will be randomized to wear samfilcon A for one month.
Other Names:
  • Ultra Multifocal for Astigmatism

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coopervision, Inc.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

July 29, 2021

Study Completion (Actual)

July 29, 2021

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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