NCT05159765.
Study name | Progressive myopia treatment evaluation for NaturalVue multifocal contact lens trial (PROTECT) |
Methods | Randomised parallel‐group design |
Participants | Inclusion criteria: aged 7 to < 13 (inclusive), SER error between −0.75 and −5.00 D, astigmatism ≤ −0.75 D, anisometropia < 1.00 D Exclusion criteria: previously worn or currently wears rigid or gas‐permeable contact lenses, including OK lenses, appears to exhibit poor personal hygiene, that, in the investigator's opinion, might prevent safe contact lens wear, current or prior use of BFs, PALs, atropine, pirenzepine, MF or specialised contact lenses, or any other myopia control treatment |
Interventions |
Intervention: MF contact lenses Comparator intervention: single vision contact lenses |
Outcomes |
Primary outcome: change in refractive error from baseline
Secondary outcome: change in AL from baseline Maximum follow up: 36 months |
Starting date | December 2021 Estimated end date: August 2025 |
Contact information | clinicaltrials.gov/ct2/show/NCT05159765 |
Notes |