Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
Running, not enrolling · Not applicable
Conditions studied: Myopia
In brief
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.
Key facts
- Study ID
- NCT05159765
- Run by
- Visioneering Technologies, Inc
- People needed
- 144
- Starts
- 2022-01-22
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-09-22
Who can join
Age: 7 and older, up to 13. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Fig Garden Optometry — Fresno, California, United States
- North Suburban Vision Consultants — Deerfield, Illinois, United States
- Cooper Eye Care — New York, New York, United States
- Bellaire Family Eye Care — Bellaire, Texas, United States
- Toronto Eye Care — Toronto, Ontario, Canada
- University of Waterloo School of Optometry — Waterloo, Ontario, Canada
- Hong Kong Polytechnic University — Tsim Sha Tsui, Hong Kong
- Myopia Specialist Centre — Singapore, Singapore
Full record on ClinicalTrials.gov
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