Visual Performance of Center Distance Daily Disposable Multifocal Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a prospective, double-masked, crossover trial.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and the examiner tasked with obtaining study outcome data will be masked to the design or brand of lenses. An unmasked examiner will be available to address any issues of lens wear or other adverse events.

Study Groups

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NaturalVue

NaturalVue Enhanced Multifocal 1 Day contact lens

Group Type ACTIVE_COMPARATOR

NaturalVue Enhanced Multifocal 1 Day contact lens

Intervention Type DEVICE

Daily disposable multifocal contact lens

MiSight

MiSight 1 Day contact lens

Group Type ACTIVE_COMPARATOR

MiSight 1 Day contact lens

Intervention Type DEVICE

Daily disposable dual-focus contact lens

Interventions

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NaturalVue Enhanced Multifocal 1 Day contact lens

Daily disposable multifocal contact lens

Intervention Type DEVICE

MiSight 1 Day contact lens

Daily disposable dual-focus contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must satisfy the following conditions for inclusion in the trial:

* Be between 9 and 30 years of age
* Sign written Informed Consent/Assent.
* Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D
* 20/20 vision in each eye
* Existing contact lens wearer
* An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available)
* No known ocular disease - anterior or posterior (posterior determined by history/chart)
* Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study.
* On examination, have ocular findings considered to be within normal limits.
* Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria

* Any of the following will exclude a participant from this trial:

* Current hard lens wearers
* Using eye medication contraindicating lens wear such as daily use of artificial tears.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* History of corneal refractive surgery
* Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Allergy or sensitivity to any product used in this trial.
* Pre-existing ocular condition that would contraindicate lens wear.
* Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses.
* Lazy eye (Strabismus or amblyopia)
* Pupil size \< 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )

Minimum Eligible Age

9 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes