Back to resultsProgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT)
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Single vision contact lenses
Multifocal contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, Refractive Error
Eligibility Criteria
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.
Sites / Locations
- Fig Garden OptometryRecruiting
- North Suburban Vision ConsultantsRecruiting
- Cooper Eye CareRecruiting
- Bellaire Family Eye CareRecruiting
- Toronto Eye CareRecruiting
- University of Waterloo School of OptometryRecruiting
- Hong Kong Polytechnic UniversityRecruiting
- Myopia Specialist CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Contact lens with refractive correction, single vision optic
Contact lens with refractive correction, multifocal optic
Outcomes
Primary Outcome Measures
Change in Refractive Error relative to Baseline
Mean change in cycloplegic auto-refraction (D)
Secondary Outcome Measures
Change in Axial Length
Mean change in Axial Length (mm)
Full Information
NCT ID
NCT05159765
First Posted
December 2, 2021
Last Updated
October 3, 2022
Sponsor
Visioneering Technologies, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05159765
Brief Title
Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
Acronym
PROTECT
Official Title
Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visioneering Technologies, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Refractive Error
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Contact lens with refractive correction, single vision optic
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Contact lens with refractive correction, multifocal optic
Intervention Type
Device
Intervention Name(s)
Single vision contact lenses
Intervention Description
Wearing contact lenses during waking hours may alter the progression of myopia
Intervention Type
Device
Intervention Name(s)
Multifocal contact lenses
Intervention Description
Wearing contact lenses during waking hours may alter the progression of myopia
Primary Outcome Measure Information:
Title
Change in Refractive Error relative to Baseline
Description
Mean change in cycloplegic auto-refraction (D)
Time Frame
Baseline, 12, 24, 36 months
Secondary Outcome Measure Information:
Title
Change in Axial Length
Description
Mean change in Axial Length (mm)
Time Frame
Baseline,12, 24, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Tuan, OD, PhD
Phone
1-844-884-5367
Ext
102
Email
atuan@vtivision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Tuan, OD, PhD
Organizational Affiliation
VTI
Official's Role
Study Chair
Facility Information:
Facility Name
Fig Garden Optometry
City
Fresno
State/Province
California
ZIP/Postal Code
93704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Krohn, OD
Phone
559-229-7202
Email
drjeffkrohn@gmail.com
Facility Name
North Suburban Vision Consultants
City
Deerfield
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Eiden, OD
Phone
847-412-0311
Email
sbeiden@nsvc.com
Facility Name
Cooper Eye Care
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cooper, OD
Phone
212-758-0772
Email
cooperjsc1@gmail.com
Facility Name
Bellaire Family Eye Care
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Tucker, OD
Phone
713-664-8087
Email
ashley.w.tucker@gmail.com
Facility Name
Toronto Eye Care
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 1A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Caffery, OD
Email
dr.b.caffery@gmail.com
Facility Name
University of Waterloo School of Optometry
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Moezzi
Phone
+1 519-888-4742
Facility Name
Hong Kong Polytechnic University
City
Tsim Sha Tsui
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Tse
Phone
+852-2766-5225
Email
myopia.protect@polyu.edu.hk
Facility Name
Myopia Specialist Centre
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Lim
Phone
96787040
Email
research@myopiaspecialistcentre.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
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