Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05598242
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2022-10-20
Brief Title:
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Sponsor:
Hospital Nacional Profesor Alejandro Posadas
Organization:
Hospital Nacional Profesor Alejandro Posadas
Study Overview
Official Title:
Amniotic Membrane Treatment for Hyposecretory Dry Eye
Status:
COMPLETED
Status Verified Date:
2022-10
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:
The goal of this randomized active-controlled parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops AMEED in reducing signs and symptoms of hyposecretory dry eye
Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th
Researchers will compare against autologous serum eye drops effects
Participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th
Researchers will compare against autologous serum eye drops effects
Detailed Description:
This was a randomized active-controlled parallel-group trial The perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation
During de initial 2 weeks screening period the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops ASED or AMEED administered as 1 drop in each eye 6 times daily respectively for 30 days
During de initial 2 weeks screening period the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops ASED or AMEED administered as 1 drop in each eye 6 times daily respectively for 30 days
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