Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363292
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI on the Ocular Surface of Healthy Subjects
Sponsor:
Laboratorios Sophia SA de CV
Organization:
Laboratorios Sophia SA de CV
Study Overview
Official Title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
Status:
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 I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events incidence of conjunctival hyperemia and chemosis changes in Best Corrected Visual Acuity BCVA changes in ocular surface integrity compared to VIGAMOXI
Detailed Description:
This is a Phase I controlled comparative parallel-group single-blind single-center controlled clinical trial The variables to be evaluated include
Primary safety
Incidence of unexpected adverse events related to the interventions
Incidence of conjunctival hyperemia and chemosis
Changes in Best Corrected Visual Acuity BCVA assessed with Snellen chart
Changes in ocular surface integrity using fluorescein staining using the standard Oxford scale
Primary tolerability
- Changes in the ocular comfort index OCI score
Secondary safety
- Incidence of unexpected adverse events related to the interventionsexcluding conjunctival hyperemia andor chemosis
Secondary tolerability
- Presence of other ocular symptoms burning foreign body sensation pruritus and lacrimation
Primary safety
Incidence of unexpected adverse events related to the interventions
Incidence of conjunctival hyperemia and chemosis
Changes in Best Corrected Visual Acuity BCVA assessed with Snellen chart
Changes in ocular surface integrity using fluorescein staining using the standard Oxford scale
Primary tolerability
- Changes in the ocular comfort index OCI score
Secondary safety
- Incidence of unexpected adverse events related to the interventionsexcluding conjunctival hyperemia andor chemosis
Secondary tolerability
- Presence of other ocular symptoms burning foreign body sensation pruritus and lacrimation
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