Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370585
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-10
Brief Title:
Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel Ofteno PF
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-229 Ophthalmic Solution Compared to Lagricel Ofteno PF in Clinically Healthy Subjects
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 I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events changes in Best Corrected Visual Acuity BCVA incidence of chemosis and changes in ocular surface staining using the Sjögrens International Collaborative Clinical Alliance SICCA Ocular Staining Score OSS scale compared to Lagricel Ofteno PF in clinically healthy subjects
Detailed Description:
The variables to be evaluated include
Primary objective
- To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel Ofteno PF in clinically healthy subjects
Specific objective
- To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF through the incidence of adverse events related to both investigational products
Secondary Objectives
To compare the safety of vs PRO-229 formulation compared to Lagricel Ofteno PF by changes in Best Corrected Visual Acuity BCVA
To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF by changes in ocular surface staining assessed with the the Sjögrens International Collaborative Clinical Alliance SICCA Ocular Staining Score OSS scale
To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF by the incidence of chemosis
To compare the tolerability of PRO-229 formulation compared to Lagricel Ofteno PF by changes in conjunctival hyperemia grades 3 or 4
To ompare the tolerability of PRO-229 formulation compared to Lagricel Ofteno Ophthalmic PF by adherence to treatment
Primary objective
- To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel Ofteno PF in clinically healthy subjects
Specific objective
- To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF through the incidence of adverse events related to both investigational products
Secondary Objectives
To compare the safety of vs PRO-229 formulation compared to Lagricel Ofteno PF by changes in Best Corrected Visual Acuity BCVA
To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF by changes in ocular surface staining assessed with the the Sjögrens International Collaborative Clinical Alliance SICCA Ocular Staining Score OSS scale
To compare the safety of PRO-229 formulation compared to Lagricel Ofteno PF by the incidence of chemosis
To compare the tolerability of PRO-229 formulation compared to Lagricel Ofteno PF by changes in conjunctival hyperemia grades 3 or 4
To ompare the tolerability of PRO-229 formulation compared to Lagricel Ofteno Ophthalmic PF by adherence to treatment
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