Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392607
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
Euclid Phoenix Lens Design Trial 2
Sponsor:
Euclid Systems Corporation
Organization:
Euclid Systems Corporation
Study Overview
Official Title:
Euclid Phoenix Lens Design Trial Part 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None