Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352541
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-02
Brief Title:
Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo
Sponsor:
Laboratorios Sophia SA de CV
Organization:
Laboratorios Sophia SA de CV
Study Overview
Official Title:
Phase I Clinical Study Evaluating Safety and Tolerability of PRO-232 an Ophthalmic Solution Versus Placebo When Applied to the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers
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:
PRO-232
Brief Summary:
This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement as well as through the incidence of stinging after its administration compared to placebo
Detailed Description:
The variables to be evaluated include
Primary safety
Unexpected adverse events
IOP
Primary tolerability
- Stinging
Secondary safety
Expected and related adverse events
BCVA
Ocular surface stining
Secondary tolerability
- Other ocular symptoms foreign body sensation and tearing
The operational definition states a difference under 15 in order to consider non inferior the safety and tolerability profile of PRO-232 compared to placebo
Primary safety
Unexpected adverse events
IOP
Primary tolerability
- Stinging
Secondary safety
Expected and related adverse events
BCVA
Ocular surface stining
Secondary tolerability
- Other ocular symptoms foreign body sensation and tearing
The operational definition states a difference under 15 in order to consider non inferior the safety and tolerability profile of PRO-232 compared to placebo
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