Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Control Lens (stenfilcon A); Device: Test Lens (senofilcon A)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05763628

EX-MKTG-144

Details and patient eligibility

About

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

Full description

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

Enrollment: 59 patients

Sex: All

Ages: 42+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Were at least 42 years of age and had full legal capacity to volunteer;

2. Had read and signed an information consent letter;

3. Self-reported having had a full eye examination in the previous two years;

4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week

5. Were willing and able to follow instructions and maintain the appointment schedule;

6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum

   • Maximum of 7 participants per site were 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 were habitual wearers of frequent replacement lenses
   • Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA

7. Had refractive astigmatism no higher than -0.75DC in each eye;

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

9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion criteria

A person was excluded from the study if they:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Control Lens, then Test Lens

Experimental group

Description:

Participants wore Control Lens for 2 weeks, then crossed over to Test Lens for 2 weeks.

Treatment:

Device: Test Lens (senofilcon A)

Device: Control Lens (stenfilcon A)

Test Lens, then Control Lens

Experimental group

Description:

Participants wore Test Lens for 2 weeks, then crossed over to Control Lens for 2 weeks.

Treatment:

Device: Test Lens (senofilcon A)

Device: Control Lens (stenfilcon A)