Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Presbyopia Clinical Trial

Official title:

Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232590
• Other study ID #: EX-MKTG-153
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Coopervision, Inc.
• Contact: José A Vega, OD PhD FAAO
• Phone: +1 (925) 621-3761
• Email: jvega2[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Description:

This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 4-6 weeks: the lens prescription of each lens type will be optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 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 spherical multifocal soft contact lenses, for the past 3 months minimum;

• Maximum of 4 participants (out of 12) per site may be habitual wearers of daily disposable lenses,
• Maximum of 4 participants (out of 12) per site may be habitual wearers of Biofinity Multifocal,
• Maximum of 4 participants (out of 12) per site may be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal

7. Has refractive astigmatism no higher than -0.75DC;

8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;

9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen 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:

1. Is participating in any concurrent clinical or research trial;

2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

7. Has undergone refractive error surgery or intraocular surgery.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Control Lens (comfilcon A)
Multifocal monthly replacement contact lens for 1 month
• Test Lens (lehfilcon A)
Multifocal monthly replacement contact lens for 1 month

Locations

Country	Name	City	State
Canada	Spadina Optometry	Toronto	Ontario
United States	ProCare Vision Center	Granville	Ohio
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	New Bremen EyeCare	New Bremen	Ohio
United States	Sacco Eye Group	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	Centre for Ocular Research & Education, Canada

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Handling for Insertion	Subjective rating at study visit will be measured using a 0-100 scale, where 0=Very difficult and 100=Very easy	1 month