Visioneering Achieves 50% Enrollment Milestone in its PROTECT International Clinical Study for Myopia
Progression Control
Highlights:
– VTI reaches 50% enrollment in its international randomized controlled clinical trial studying
its NaturalVue® Multifocal Contact Lenses in myopia progression control
– This milestone underscores the Company’s commitment to invest in research and
development and to leverage its leadership position myopia progression control
– The Company expects to have interim 1-year data from the PROTECT Clinical Study in
the second half of 2023.
US-based medical device company and producer of the NaturalVue® Multifocal 1 Day Contact Lenses,
Visioneering Technologies, Inc (ASX:VTI) (‘Visioneering’, ‘VTI’ or ‘the Company’), today
announced it has enrolled 50% of the subjects in its international randomized controlled clinical
trial known as ‘PROTECT’ (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal
Contact Lens Trial). The study objective is to demonstrate and quantify the effectiveness of its
NaturalVue® Multifocal Contact Lenses in myopia progression control in children. PROTECT is a
multi-center, randomized, double-masked clinical trial with participating investigators in centers in
Canada, the United States, and Hong Kong with an additional site planned in Singapore.
The trial is designed to enroll 144 healthy nearsighted children (myopes) from 7 to <13 years of
age whose current prescription is between -0.75D and -5.00D. Primary outcomes will be
determined by the respective changes over time in refractive error progression and eye length,
both important markers of myopia progression. VTI expects that the data will demonstrate the
superiority of NaturalVue Multifocal over the control lens in managing myopia progression, thus
providing an important data point for practitioners and VTI’s corporate partnering activities and
corroborating the conclusions of the recently reported analysis of 6-year real-world data for
NaturalVue® Multifocal.
The Company expects to complete trial enrollment in September 2022. In previous myopia control
trials of this type, one-year follow up data has been shown to be a strong predictor of overall trial
outcomes. VTI expects to release one-year follow up data from PROTECT in the second half of
2023, with longer-term data expected in the second half of 2024 and final results in the second
half of 2025.
The study reached 50% enrollment, or 72 subjects, on 12 July 2022. Importantly, there have been
no safety concerns to date. The landmark study has enrolled subjects in sites in Toronto and
Waterloo in Canada; Hong Kong; and in New York, Chicago, Houston and Fresno, CA in the
United States.
1 Visioneering Technologies, Inc. (ASX:VTI) • www.vtivision.com • www.vtivisioninvestors.com
10745 Westside Way • #200 • Alpharetta, GA 30009 • E: info@vtivision.com • P: +1-844-884-5367)
VTI’s Chief Medical Officer, Dr. Ashley Tuan, commented: “The principal investigators at our
existing sites have embraced the PROTECT Clinical Study. We are pleased with the progress to
date and look forward to adding our final site and reaching full enrollment. We believe the results
of the PROTECT Clinical Study will corroborate our real-world data that showed a significant
positive impact of NaturalVue Multifocal, making it an excellent choice for the management of
myopia. We greatly appreciate the efforts of those independent eye care professionals serving as
principal investigators in this study and their commitment to providing the highest quality evidence
of the effectiveness of this outstanding product.”