Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

CooperVision

Status: Enrolling

Conditions: Presbyopia

Treatments: Device: Test Lens (lehfilcon A); Device: Control Lens (comfilcon A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06232590

EX-MKTG-153

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 42+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control Lens, then Test Lens

Experimental group

Description:

Participants will wear the Control Lens for 1 month, then the Test Lens for 1 month

Treatment:

Device: Test Lens (lehfilcon A)

Device: Control Lens (comfilcon A)

Test Lens, then Control Lens

Experimental group

Description:

Participants will wear the Test Lens for 1 month, then the Control Lens for 1 month

Treatment:

Device: Test Lens (lehfilcon A)

Device: Control Lens (comfilcon A)