Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Presbyopia Clinical Trial

Official title:

Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404725
• Other study ID #: EX-MKTG-110
• Status: Completed
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: July 29, 2021

Study information

• Verified date: February 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Presbyopia

Intervention

Device:
• comfilcon A
Subjects will be randomized to wear comfilcon A for one month.
• Samfilcon A
Subjects will be randomized to wear samfilcon A for one month.

Locations

Country	Name	City	State
Canada	Glasses Half Full	Edmonton	Alberta
Canada	Dolman Eyecare Centre	New Hamburg	Ontario
Canada	Spadina Optometry	Toronto	Ontario
Canada	Lyndon Jones	Waterloo	Ontorio
Canada	Oakley Eyecare	Winnipeg	Manitoba
United States	Athens Eye care	Athens	Ohio
United States	Nittany Eye Associates	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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