Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)

Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

42 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Is at least 42 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears multifocal soft contact lenses, for the past 3 months minimum^; Maximum of 7 participants per site should be 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 should be habitual wearers of frequent replacement lenses Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA Has refractive astigmatism no higher than -0.75DC; Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D; 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 (Distance sphere +4 to -6; near addition as per study design). Exclusion Criteria: Is participating in any concurrent clinical or research trial; Has any known active* ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Sites / Locations

Sacco Eye Group PLLC
Athens Eye Care- Dr. Shane Foster & Associates
Bellaire Family Eye Care
Eyes on Sheppard Clinic
Spadina Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control Contact Lens, Then Test Contact Lens

Test Contact Lens, Then Control Contact Lens

Arm Description

Participants will wear control contact lenses for two weeks and then crossover to test contact lenses for two weeks.

Participants will wear test contact lenses for two weeks and then crossover to control contact lenses for two weeks.

Outcomes

Primary Outcome Measures

Lens Handling for Removal

Lens Handling for Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

Secondary Outcome Measures

Full Information

NCT ID

NCT05763628

First Posted

February 21, 2023

Last Updated

April 12, 2023

Sponsor

Coopervision, Inc.

Collaborators

CORE

1. Study Identification

Unique Protocol Identification Number

NCT05763628

Brief Title

Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Official Title

Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 5, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

Collaborators

CORE

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

Detailed Description

This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 3-4 weeks: the lens prescription of each lens type will be optimized after 3-8 days wearing experience, prior to starting a 2-week (14-21 day) wear period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Contact Lens, Then Test Contact Lens

Arm Type

Experimental

Arm Description

Participants will wear control contact lenses for two weeks and then crossover to test contact lenses for two weeks.

Arm Title

Test Contact Lens, Then Control Contact Lens

Arm Type

Experimental

Arm Description

Participants will wear test contact lenses for two weeks and then crossover to control contact lenses for two weeks.

Intervention Type

Device

Intervention Name(s)

Control Contact Lens (stenfilcon A Daily Disposable Multifocal Contact Lens)

Intervention Description

two weeks of wear

Intervention Type

Device

Intervention Name(s)

Test Contact Lens (senofilcon A Daily Disposable Multifocal Contact Lens)

Intervention Description

two weeks of wear

Primary Outcome Measure Information:

Title

Lens Handling for Removal

Description

Lens Handling for Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

Time Frame

2 weeks of wear

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is at least 42 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears multifocal soft contact lenses, for the past 3 months minimum^; Maximum of 7 participants per site should be 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 should be habitual wearers of frequent replacement lenses Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA Has refractive astigmatism no higher than -0.75DC; Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D; 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 (Distance sphere +4 to -6; near addition as per study design). Exclusion Criteria: Is participating in any concurrent clinical or research trial; Has any known active* ocular disease and/or infection that contraindicates contact lens wear; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

Overall Study Officials: