Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-12
Brief Title:
Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive
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-240 Ophthalmic Solution Compared to Optive on 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:
None
Brief Summary:
This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events as well as through changes in Best Corrected Visual Acuity BCVA and the incidence of stinging after its administration compared to Optive
Detailed Description:
The variables to be evaluated include
Primary safety
- Incidence of unexpected advere events AEs
Secondary
Changes in the ocular comfort index OCI score
Changes in intraocular pressure IOP
Changes in Best Corrected Visual Acuity BCVA
Adherence to treatment
Changes in tear film breakup time
Changes in fluorescein staining
Changes in lissamine green staining
Primary safety
- Incidence of unexpected advere events AEs
Secondary
Changes in the ocular comfort index OCI score
Changes in intraocular pressure IOP
Changes in Best Corrected Visual Acuity BCVA
Adherence to treatment
Changes in tear film breakup time
Changes in fluorescein staining
Changes in lissamine green staining
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