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Clinical Evaluation of Two Multifocal Contact Lenses

NCT ID: NCT05457608

Last Updated: 2023-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-25

Study Completion Date

2022-08-13

Brief Summary

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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

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

Conditions

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Presbyopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All participants received Lens A and then Lens B in fixed-sequence order.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens A

All participants wore lens A for 15 minutes (Period 1)

Group Type EXPERIMENTAL

Lens A

Intervention Type DEVICE

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

Lens B

All participants wore lens B for 15 minutes (Period 2)

Group Type EXPERIMENTAL

Lens B

Intervention Type DEVICE

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

Interventions

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Lens A

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

Intervention Type DEVICE

Lens B

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rubén V Guerrero, MSc, FIACLE

Role: PRINCIPAL_INVESTIGATOR

School of Optometry, National Autonomous University (UNAM)

Locations

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School of Optometry Clinic, National Autonomous University (UNAM)

Mexico City, , Mexico

Site Status

Countries

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Mexico

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EX-MKTG-136

Identifier Type: -

Identifier Source: org_study_id