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Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Primary Purpose

Astigmatism, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

comfilcon A

Samfilcon A

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Athens Eye care
Nittany Eye Associates
Glasses Half Full
Oakley Eyecare
Dolman Eyecare Centre
Spadina Optometry
Lyndon Jones

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

comfilcon A then samfilcon A

samfilcon A then comfilcon A

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04404725

First Posted

May 22, 2020

Last Updated

February 9, 2022

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04404725

Brief Title

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Official Title

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

August 6, 2020 (Actual)

Primary Completion Date

July 29, 2021 (Actual)

Study Completion Date

July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism, Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

comfilcon A then samfilcon A

Arm Type

Experimental

Arm Description

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

Arm Title

samfilcon A then comfilcon A

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

comfilcon A

Other Intervention Name(s)

Biofinity Toric Multifocal

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Samfilcon A

Other Intervention Name(s)

Ultra Multifocal for Astigmatism

Intervention Description

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

Primary Outcome Measure Information:

Title

Ease of Lens Handling at Insertion

Description

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

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials: