NCT06392607

Euclid Phoenix Lens Design Trial 2

Euclid Phoenix Lens Design Trial Part 2

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Euclid Systems Corporation · Industry
• Sex: All
• Age: 6 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Lens wettability and subjective comfort of Euclid orthokeratology lenses with and without an enhanced coating will be compared in 50 children. Axial elongation will be monitored in pediatric patients who qualify and consent.

Detailed description

The primary objective of this trial is to provide an assessment of the lens wettability and patient comfort with an enhanced surface treatment for the Emerald Lens design when used by practitioners with moderate experience with fitting Euclid orthokeratology lenses. The hypothesis to be tested is that the proportion of participants with a lens wettability score of \> 3 (on a 5 point scale) with the enhanced surface treatment will be greater than that of the current lens surface, using a 1 to 5 scale The primary outcome variable is lens wettability as measured on eye using a 1 to 5 scale This clinical investigation will be a prospective, randomized, double-masked two-arm non-crossover trial.

Conditions

• Myopia
• Cornea

Interventions

Type	Name	Description
DEVICE	Euclid orthokeratology (standard coating)	Lens with the current coating
DEVICE	Euclid orthokeratology (enhanced coating)	Lens with the enhanced coating

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study