PROTECT: Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Sponsor

Visioneering Technologies, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05159765

Collaborator

(none)

144

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive	Device: Single vision contact lenses Device: Multifocal contact lenses	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Contact lens with refractive correction, single vision optic	Device: Single vision contact lenses Wearing contact lenses during waking hours may alter the progression of myopia
Experimental: Treatment Contact lens with refractive correction, multifocal optic	Device: Multifocal contact lenses Wearing contact lenses during waking hours may alter the progression of myopia

Arm

Intervention/Treatment

Placebo Comparator: Control

Contact lens with refractive correction, single vision optic

Device: Single vision contact lenses

Wearing contact lenses during waking hours may alter the progression of myopia

Experimental: Treatment

Contact lens with refractive correction, multifocal optic

Device: Multifocal contact lenses

Wearing contact lenses during waking hours may alter the progression of myopia

Outcome Measures

Primary Outcome Measures

Change in Refractive Error relative to Baseline [Baseline, 12, 24, 36 months]
Mean change in cycloplegic auto-refraction (D)

Secondary Outcome Measures

Change in Axial Length [Baseline,12, 24, 36 months]
Mean change in Axial Length (mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.
Meet the following refractive criteria determined by cycloplegic autorefraction at

Screening/Baseline:

Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
Astigmatism: ≤ -0.75 D
Anisometropia: < 1.000

Exclusion Criteria:

Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYC	New York	New York	United States	10065
2	Toronto Eye Care	Toronto	Ontario	Canada	M4W 1A5

Sponsors and Collaborators

Visioneering Technologies, Inc

Investigators

Study Chair: Ashley Tuan, OD, PhD, VTI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Visioneering Technologies, Inc

ClinicalTrials.gov Identifier:

NCT05159765

Other Study ID Numbers:

VTI-NVMF-MPC-RCT-001

First Posted:

Dec 16, 2021

Last Update Posted:

Dec 16, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Keywords provided by Visioneering Technologies, Inc

myopia, refractive errors

Additional relevant MeSH terms:

Myopia

Myopia, Degenerative

Study Results

No Results Posted as of Dec 16, 2021