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Comparing the Performance of 1 Day Multifocal Contact Lenses

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lens A

Lens B

Habitual Lenses

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

Exclusion Criteria:

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
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

Scripps Poway Eyecare
Golden Optometric Group
Golden Vision
Kannarr Eye Care
ProCare Vision Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Lens A (Test)

Lens B (Control)

Habitual Lenses

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Subjective At-home Ratings for Ease of Lens Handling for Insertion

Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)

Secondary Outcome Measures

Full Information

NCT ID

NCT04449263

First Posted

June 24, 2020

Last Updated

June 18, 2021

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04449263

Brief Title

Comparing the Performance of 1 Day Multifocal Contact Lenses

Official Title

Comparing the Performance of 1 Day Multifocal Contact Lenses

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 27, 2020 (Actual)

Primary Completion Date

December 7, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

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 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.

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

Lens A (Test)

Arm Type

Experimental

Arm Description

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

Arm Title

Lens B (Control)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Habitual Lenses

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Lens A

Other Intervention Name(s)

FDA Approved, non-marketed, daily disposable multifocal lens

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Lens B

Other Intervention Name(s)

FDA Approved, daily disposable multifocal lens

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Habitual Lenses

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective At-home Ratings for Ease of Lens Handling for Insertion

Description

Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)

Time Frame

Day 13

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; 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 (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH). Exclusion Criteria: Is participating in any concurrent clinical or research study; Habitually wears one of the study contact lenses; 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: