Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763628
• Other study ID #: EX-MKTG-144
• Status: Completed
• Phase: N/A
• Start date: December 10, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to compare the lens performance of two daily disposable multifocal contact lenses.

Description:

This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 3-4 weeks: the lens prescription of each lens type will be optimized after 3-8 days wearing experience, prior to starting a 2-week (14-21 day) wear period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years and older

Eligibility

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 multifocal soft contact lenses, for the past 3 months minimum^;
• Maximum of 7 participants per site should be habitual wearers of daily disposable lenses
• Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
• Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
• Maximum of 3 habitual wearers per site of MyDay Multifocal
• Maximum of 7 participants per site should be habitual wearers of frequent replacement lenses
• Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
• Has refractive astigmatism no higher than -0.75DC;
• Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
• 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 (Distance sphere +4 to -6; near addition as per study design).

Exclusion Criteria:

• Is participating in any concurrent clinical or research trial;
• Has any known active* ocular disease and/or infection that contraindicates contact lens wear;
• 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 used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)
two weeks of wear
• Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)
two weeks of wear

Locations

Country	Name	City	State
Canada	Eyes on Sheppard Clinic	Toronto	Ontario
Canada	Spadina Optometry	Toronto	Ontario
United States	Athens Eye Care- Dr. Shane Foster & Associates	Athens	Ohio
United States	Bellaire Family Eye Care	Bellaire	Texas
United States	Sacco Eye Group PLLC	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling for Removal	Lens Handling for Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)	2 weeks of wear