Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

NCT05763628 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-144
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Lens Handling for Removal

  Subjective rating for ease of removal of the study lenses on a 0-100 scale, where 0=Very difficult and 100=Very easy. Collected once at the end of 2 weeks of wear.

  2 Weeks

Study Arms (2)

Control Lens, then Test Lens

EXPERIMENTAL

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

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

Test Lens, then Control Lens

EXPERIMENTAL

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

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

Interventions

Control Lens (stenfilcon A) DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Control Lens, then Test Lens; Test Lens, then Control Lens

Test Lens (senofilcon A) DEVICE

Daily Disposable Multifocal Contact Lens for 2 weeks

Control Lens, then Test Lens; Test Lens, then Control Lens

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were at least 42 years of age and had full legal capacity to volunteer;
• Had read and signed an information consent letter;
• Self-reported having had a full eye examination in the previous two years;
• Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
• Were willing and able to follow instructions and maintain the appointment schedule;
• 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
• Had refractive astigmatism no higher than -0.75DC in each eye;
• Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
• 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)

You may not qualify if:

• A person was excluded from the study if they:
• Were participating in any concurrent clinical or research study;
• Had any known active ocular disease and/or infection that contraindicated contact lens wear;
• Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
• 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;
• Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
• Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Had undergone refractive error surgery or interocular surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (5)

Sacco Eye Group PLLC

Vestal, New York, 13850, United States

Location

Athens Eye Care- Dr. Shane Foster & Associates

Athens, Ohio, 45701, United States

Location

Bellaire Family Eye Care

Bellaire, Texas, 77401, United States

Location

Eyes on Sheppard Clinic

Toronto, Ontario, M2N 3A1, Canada

Location

Spadina Optometry

Toronto, Ontario, M5V 3E7, Canada

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega OD, PhD, MSc, FAAO
• Organization: CooperVision Inc.

jvega2@coopervision.com

+19256213761

Study Officials

• David Wilkinson

  Spadina Optometry

  PRINCIPAL INVESTIGATOR

• Ashley Tucker

  Bellaire Family Eye Care

  PRINCIPAL INVESTIGATOR

• Fiona Soong

  Eyes on Sheppard Clinic

  PRINCIPAL INVESTIGATOR

• Andrew Sacco

  Sacco Eye Group PLLC

  PRINCIPAL INVESTIGATOR

• Shane Foster

  Athens Eye Care - Dr. Shane Foster & Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 10, 2023
• Study Start: December 10, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2023-03

Locations

US (3); CA (2)