Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379685
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-15
Brief Title:
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra on the Ocular Surface
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-190 Ophthalmic Solution Compared to Systane Ultra 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 evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events changes in Best Corrected Visual Acuity BCVA changes in ocular surface integrity changes in the ocular comfort index OCI score and IOP measurement compared to Systane Ultra
Detailed Description:
The variables to be evaluated include
Primary safety
Incidence Unexpected Related Adverse Reactions
Secondary
Changes in the ocular comfort index OCI score in between interventions Changes in Best Corrected Visual Acuity BCVA Changes in tear film breakup time Changes in intraocular pressure IOP Changes in the integrity of the ocular surface fluorescein staining Changes in lissamine green staining
Primary safety
Incidence Unexpected Related Adverse Reactions
Secondary
Changes in the ocular comfort index OCI score in between interventions Changes in Best Corrected Visual Acuity BCVA Changes in tear film breakup time Changes in intraocular pressure IOP Changes in the integrity of the ocular surface 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