Evaluating Two Multifocal Daily Disposable Contact Lenses

NCT ID: NCT05579886

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2023-02-07

Brief 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.

Detailed Description

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

Conditions

Presbyopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Lens

All participants wore the Control Lens for 2 weeks (Period 1)

Group Type: ACTIVE_COMPARATOR

Control Lens

Intervention Type: DEVICE

Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks

Test Lens

All participants wore the Test Lens for 2 weeks (Period 2)

Group Type: EXPERIMENTAL

Test Lens

Intervention Type: DEVICE

Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Interventions

Control Lens

Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks

Intervention Type: DEVICE

Test Lens

Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Sacco

Role: PRINCIPAL_INVESTIGATOR

Sacco Eye Group

Shane Kannarr

Role: PRINCIPAL_INVESTIGATOR

Kannarr Eye Care

Katherine Bickle

Role: PRINCIPAL_INVESTIGATOR

ProCare Vision Center

Michael Cymbor

Role: PRINCIPAL_INVESTIGATOR

Nittany Eye Associates

Roxanne Achong-Coan

Role: PRINCIPAL_INVESTIGATOR

Coan Eye Care & Optical Boutique

Locations

Coan Eye Care & Optical Boutique

Ocoee, Florida, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Center

Granville, Ohio, United States

Nittany Eye Associates

State College, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-140

Identifier Type: -

Identifier Source: org_study_id