Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373653
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Study of Non-inferiority Between Manzanilla Sophia and Meticel Ofteno 05 for Providing a Soothing Sensation to the Eyes
Sponsor:
Laboratorios Sophia SA de CV
Organization:
Laboratorios Sophia SA de CV
Study Overview
Official Title:
Clinical Study of Non-inferiority Between Manzanilla Sophia and Meticel Ofteno 05 for Providing a Soothing Sensation to the Eyes
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:
This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia compared to Meticel Ofteno 05 in providing restful sensation to the eyes This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application when applied by the Principal Investigator PI
Detailed Description:
Primary
-Analog visual eyestrain test score
Secondary
Incidence of unexpected adverse events related to the interventions
Incidence of conjunctival hyperemia
Incidence of sensation of ocular dryness
Incidence of ocular irritation
Incidence of sensation of sleep-crust
Incidence of sensation of comfort with the application when applied by the Principal Investigator PI
-Analog visual eyestrain test score
Secondary
Incidence of unexpected adverse events related to the interventions
Incidence of conjunctival hyperemia
Incidence of sensation of ocular dryness
Incidence of ocular irritation
Incidence of sensation of sleep-crust
Incidence of sensation of comfort with the application when applied by the Principal Investigator PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None