Evaluating Two Multifocal Daily Disposable Contact Lenses

Presbyopia Clinical Trial

Official title:

Evaluating the Success of Refitting Lens Wearers With MyDay Multifocal, Who Are Already Adapted to Clariti 1Day Multifocal 2-Add Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579886
• Other study ID #: EX-MKTG-140
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: January 2024
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years and older

Eligibility

Inclusion Criteria:

A person was eligible for inclusion in the study if he/she:

1. Was 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. Was willing and able to follow instructions and maintain the appointment schedule;

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

the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);

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

8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;

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)

Exclusion Criteria:

A person was excluded from the study if he/she:

1. Was 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. Was 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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Control Lens
Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks
• Test Lens
Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Locations

Country	Name	City	State
United States	ProCare Vision Center	Granville	Ohio
United States	Coan Eye Care & Optical Boutique	Ocoee	Florida
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Nittany Eye Associates	State College	Pennsylvania
United States	Sacco Eye Group	Vestal	New York

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	CORE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort Just After Lens Insertion	Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.	2 weeks