Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03019627
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2017-01-11
Brief Title:
An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
An 8-week Phase II Single-center Randomized Double-masked Vehicle-controlled Parallel-group Study With 4 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Patients With Dry Eye
Status:
COMPLETED
Status Verified Date:
2018-10
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 primary objective of this study was to assess the efficacy and safety of rhNGF when administered as eye drops to patients with dry eye
The secondary objectives of this study were
To assess change from baseline in Symptom Assessment In Dry Eye SANDE scores without imputation corneal and conjunctival staining according to National Eye Institute NEI scale and in Tear Film Break-up Time TFBUT and Schirmer test I following 4 and 8 weeks of treatment
To assess change in levels of inflammatory biomarker matrix metallopeptidase 9 MMP-9 in tears following 8 weeks of treatment
To assess the incidence and frequency of treatment-emergent adverse events TEAEs following 8 weeks of treatment
The secondary objectives of this study were
To assess change from baseline in Symptom Assessment In Dry Eye SANDE scores without imputation corneal and conjunctival staining according to National Eye Institute NEI scale and in Tear Film Break-up Time TFBUT and Schirmer test I following 4 and 8 weeks of treatment
To assess change in levels of inflammatory biomarker matrix metallopeptidase 9 MMP-9 in tears following 8 weeks of treatment
To assess the incidence and frequency of treatment-emergent adverse events TEAEs following 8 weeks of treatment
Detailed Description:
The proposed phase II study is a single-center randomized double-masked parallel-arm vehicle-controlled trial designed to evaluate the safety and efficacy of Recombinant Human Nerve Growth Factor rhNGF eye drops at 20 μgml concentration administered six times daily for 8 weeks in patients with dry eye After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 21 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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