Back to results

Evaluating Two Multifocal Daily Disposable Contact Lenses

Primary Purpose

Presbyopia

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Control Contact Lens

Test 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;
Has refractive astigmatism no higher than -0.75DC in each eye;
Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D in each eye;
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 (powers +4.00 to -6.00DS)

Exclusion Criteria:

Is participating in any concurrent clinical or research study;
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
Athens Eye Care
Bellaire Family Eye Care
Eyes on Sheppard Clinic
Spadina Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Contact Lens

Test Contact Lens

Arm Description

Subjects will wear Control contact lens for the first period of 2 weeks (14-21 days) and Test contact lens for the second period of 2 weeks (14-21 days).

Subjects will wear Test contact lens for the second period of 2 weeks (14-21 days).

Outcomes

Primary Outcome Measures

Comfort Just After Lens Insertion

Comfort Just After Lens Insertion will be measured on a scale of 0-10 ratings, where 0=Painful, 10=Can't feel the lenses

Secondary Outcome Measures

Full Information

NCT ID

NCT05579886

First Posted

October 11, 2022

Last Updated

April 17, 2023

Sponsor

Coopervision, Inc.

Collaborators

CORE

1. Study Identification

Unique Protocol Identification Number

NCT05579886

Brief Title

Evaluating Two Multifocal Daily Disposable Contact Lenses

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 13, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

June 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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of the study is 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 is a prospective, bilateral eye, open label, daily wear switch study involving daily disposable multifocal lenses. There will be no randomisation.

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

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Contact Lens

Arm Type

Active Comparator

Arm Description

Subjects will wear Control contact lens for the first period of 2 weeks (14-21 days) and Test contact lens for the second period of 2 weeks (14-21 days).

Arm Title

Test Contact Lens

Arm Type

Experimental

Arm Description

Subjects will wear Test contact lens for the second period of 2 weeks (14-21 days).

Intervention Type

Device

Intervention Name(s)

Control Contact Lens

Other Intervention Name(s)

Multifocal Daily Disposable Contact Lens

Intervention Description

Control Contact Lens - first period of 2 weeks (14-21 days)

Intervention Type

Device

Intervention Name(s)

Test Contact Lens

Other Intervention Name(s)

Multifocal Daily Disposable Contact Lens

Intervention Description

Test Contact Lens - second period of 2 weeks (14-21 days)

Primary Outcome Measure Information:

Title

Comfort Just After Lens Insertion

Description

Comfort Just After Lens Insertion will be measured on a scale of 0-10 ratings, where 0=Painful, 10=Can't feel the lenses

Time Frame

2 weeks

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; Has refractive astigmatism no higher than -0.75DC in each eye; Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D in each eye; 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 (powers +4.00 to -6.00DS) Exclusion Criteria: Is participating in any concurrent clinical or research study; 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: