Comparing the Performance of 1 Day Multifocal Contact Lenses

NCT ID: NCT04449263

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2020-12-30

Brief Summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Detailed Description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lens A (Test)

Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.

Group Type: EXPERIMENTAL

Lens A

Intervention Type: DEVICE

Subjects will be randomized to wear Lens A (test) for 2 weeks.

Lens B

Intervention Type: DEVICE

Subjects will be randomized to wear Lens B (control) for 2 weeks.

Habitual Lenses

Intervention Type: DEVICE

All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Lens B (Control)

Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.

Group Type: ACTIVE_COMPARATOR

Lens A

Intervention Type: DEVICE

Subjects will be randomized to wear Lens A (test) for 2 weeks.

Lens B

Intervention Type: DEVICE

Subjects will be randomized to wear Lens B (control) for 2 weeks.

Habitual Lenses

Intervention Type: DEVICE

All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Habitual Lenses

All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.

Group Type: ACTIVE_COMPARATOR

Habitual Lenses

Intervention Type: DEVICE

All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Interventions

Lens A

Subjects will be randomized to wear Lens A (test) for 2 weeks.

Intervention Type: DEVICE

Lens B

Subjects will be randomized to wear Lens B (control) for 2 weeks.

Intervention Type: DEVICE

Habitual Lenses

All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Intervention Type: DEVICE

Other Intervention Names

FDA Approved, non-marketed, daily disposable multifocal lens; FDA Approved, daily disposable multifocal lens

Eligibility Criteria

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 (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;

2. Habitually wears one of the study contact lenses;

3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;

4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

8. Has undergone refractive error surgery or intraocular surgery.

• Minimum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne Golden

Role: PRINCIPAL_INVESTIGATOR

Golden Vision

Keith Wan

Role: PRINCIPAL_INVESTIGATOR

Scripps Poway Eyecare

Shane Kannarr

Role: PRINCIPAL_INVESTIGATOR

Kannarr Eye Care

David Ardaya

Role: PRINCIPAL_INVESTIGATOR

Golden Optometric Group

Katherine Bickle

Role: PRINCIPAL_INVESTIGATOR

ProCare Vision Center

Locations

Scripps Poway Eyecare

San Diego, California, United States

Golden Optometric Group

Whittier, California, United States

Golden Vision

Sarasota, Florida, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

ProCare Vision Center

Granville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-109

Identifier Type: -

Identifier Source: org_study_id