Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT06363292
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
Sponsor:
Laboratorios Sophia S.A de C.V.
Organization:
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:
COMPLETED
Status Verified Date:
2025-06
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 interventions(excluding conjunctival hyperemia and/or 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 interventions(excluding conjunctival hyperemia and/or chemosis).
Secondary (tolerability):
\- Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).
Study Oversight
Has Oversight DMC:
True
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?: