Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655441
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
The Effects of 3 Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of 3 Trehalose Ophthalmic Solution on Corneal Epithelial Barrier Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to evaluate the effects of trehalose an ingredient found in commercially available artificial tears on the corneal barrier function The investigators will assess corneal dryness and measure the relative corneal epithelial barrier function the degree to which the cornea can prevent penetration of sodium fluorescein dye into the eye after using eye drops that contain 3 trehalose for one month
Detailed Description:
The aim of this study is to recruit moderate to severe dry eye subjects enroll them in a randomized contralateral eye-controlled trial with an ophthalmic solution containing trehalose 3 in sterile borate buffered saline in one eye and sterile buffered saline in the contralateral eye The investigators will accomplish this by enrolling a clinic-based sample undertaking a standardized examination involving signs and symptoms of dry eye fluorometry as well as clinical tear and ocular surface measures at baseline and at one-month post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None