Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317922
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-12
Brief Title:
Evaluation of Dry Eye Diseases Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections
Sponsor:
Francesco Bandello
Organization:
IRCCS Ospedale San Raffaele
Study Overview
Official Title:
Evaluation of Dry Eye Diseases Signs in Patients Who Were Administered Intravitreal Injections
Status:
RECRUITING
Status Verified Date:
2024-03
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:
DRYEYE-IVT
Brief Summary:
The goal of this interventional monocentric prospective single-masked case-control study is to evaluate the efficacy of Thealoz Duo artificial tear containing trehalose 3 g and hyaluronic acid 015 g in comparison to a saline solution Hydrabak containing Sodium Chloride 09 g Sodium Dihydrogen Phosphate Dihydrate Disodium Hydrogen Phosphate Dodecahydrate to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections
The main questions it aims to answer are
can ocular instillation of Thealoz Duo solution 1 week before intravitreal injection in a fixed dose regimen prevent ocular surface changes and dry-eye signs
can ocular instillation of Thealoz Duo solution up 3 months after intravitreal injections in a fixed dose regimen reduce ocular surface changes and dry-eye signs with improvement of quality of life and quality of vision
Each participant will be randomized into each of two arms
1 TREATMENT ARM patients who will receive the instillation of Thealoz Duo 10 ml 1 drop 4 timesday
2 CONTROL ARM patients who will receive the instillation of saline solution Hydrabak 10 ml 1 drop 4 times day
The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcomes achievement
In any case the instillation of saline solution should not alter the ocular surface
The main questions it aims to answer are
can ocular instillation of Thealoz Duo solution 1 week before intravitreal injection in a fixed dose regimen prevent ocular surface changes and dry-eye signs
can ocular instillation of Thealoz Duo solution up 3 months after intravitreal injections in a fixed dose regimen reduce ocular surface changes and dry-eye signs with improvement of quality of life and quality of vision
Each participant will be randomized into each of two arms
1 TREATMENT ARM patients who will receive the instillation of Thealoz Duo 10 ml 1 drop 4 timesday
2 CONTROL ARM patients who will receive the instillation of saline solution Hydrabak 10 ml 1 drop 4 times day
The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcomes achievement
In any case the instillation of saline solution should not alter the ocular surface
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None