Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Test lenses; Device: Control lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04952701

EX-MKTG-119

Details and patient eligibility

About

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Full description

This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.

Enrollment: 63 patients

Sex: All

Ages: 42+ years old

Volunteers: Accepts 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 multifocal soft contact lenses, for the past 3 months minimum;

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 (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Exclusion criteria

1. Is participating in any concurrent clinical or research study;
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: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Control Lens

Active Comparator group

Description:

All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.

Treatment:

Device: Control lenses

Device: Test lenses

Test Lens

Experimental group

Description:

After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.

Treatment:

Device: Control lenses

Device: Test lenses