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Clinical Evaluation of Two Multifocal Contact Lenses

Primary Purpose

Presbyopia

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Lens A

Lens B

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, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, 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 (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

School of Optometry Clinic, National Autonomous University (UNAM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lens A, Then Lens B

Arm Description

Participants will wear Lens A for 15 minutes and then wear Lens B for 15 minutes.

Outcomes

Primary Outcome Measures

Subjective Comfort Ratings on Insertion

Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.

Secondary Outcome Measures

Full Information

NCT ID

NCT05457608

First Posted

July 11, 2022

Last Updated

August 29, 2023

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05457608

Brief Title

Clinical Evaluation of Two Multifocal Contact Lenses

Official Title

Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

June 25, 2022 (Actual)

Primary Completion Date

August 13, 2022 (Actual)

Study Completion Date

August 13, 2022 (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

Yes

5. Study Description

Brief Summary

The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

Detailed Description

This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lens A, Then Lens B

Arm Type

Experimental

Arm Description

Participants will wear Lens A for 15 minutes and then wear Lens B for 15 minutes.

Intervention Type

Device

Intervention Name(s)

Lens A

Intervention Description

monthly replacement multifocal silicone hydrogel contact lens 15 minutes of daily wear

Intervention Type

Device

Intervention Name(s)

Lens B

Intervention Description

daily disposable multifocal silicone hydrogel contact lens 15 minutes of daily wear

Primary Outcome Measure Information:

Title

Subjective Comfort Ratings on Insertion

Description

Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.

Time Frame

At insertion

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, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, 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 (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:

First Name & Middle Initial & Last Name & Degree

Rubén V Guerrero, MSc, FIACLE

Organizational Affiliation

School of Optometry, National Autonomous University (UNAM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Optometry Clinic, National Autonomous University (UNAM)

City

Mexico City

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Two Multifocal Contact Lenses

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