Ignite Creation Date:
2025-12-18 @ 9:03 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT03833882
Status:
None
Last Update Posted:
2019-07-15 00:00:00
First Post:
2019-01-31 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of MAF-1217 in Patients With DED
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
Status:
None
Status Verified Date:
2019-07
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:
Patients will be enrolled after having signed the informed consent form prior any other study procedure and after inclusion/exclusion criteria check.
Each patient will be planned to perform 6 study visits and at each visit all necessary study procedures will be performed according to the clinical investigation plan requirements (see flow-chart).
The study visits will be performed at: screening, baseline, week 2, week 6, week 8, week 12.
Patients will be enrolled at screening visit and at baseline, after the wash-out period of 1 week, then will be randomized to receive MAF-1217 or Cationorm® for the following 6 weeks.
After this time lapse, patients will be switched to the opposite therapy for 6 additional weeks.
The entire study population will be asked for a TID posology, and will be divided in 4 different subgroups, according to the different types of evaporative DED.
Certain test will be performed only in some patients:
Osmolimetry and tear sampling in 20 patients(10/site) chosen random from groups B, C and D; Ferning test only in group D; tear film collection and cytokine expression only in 20 patients form site nr. 2.
Patients will be allowed to carry on any systemic or local medications, apart lubricating eyedrops, which have to be stopped the day before baseline visit.
Each patient will be planned to perform 6 study visits and at each visit all necessary study procedures will be performed according to the clinical investigation plan requirements (see flow-chart).
The study visits will be performed at: screening, baseline, week 2, week 6, week 8, week 12.
Patients will be enrolled at screening visit and at baseline, after the wash-out period of 1 week, then will be randomized to receive MAF-1217 or Cationorm® for the following 6 weeks.
After this time lapse, patients will be switched to the opposite therapy for 6 additional weeks.
The entire study population will be asked for a TID posology, and will be divided in 4 different subgroups, according to the different types of evaporative DED.
Certain test will be performed only in some patients:
Osmolimetry and tear sampling in 20 patients(10/site) chosen random from groups B, C and D; Ferning test only in group D; tear film collection and cytokine expression only in 20 patients form site nr. 2.
Patients will be allowed to carry on any systemic or local medications, apart lubricating eyedrops, which have to be stopped the day before baseline visit.
Detailed Description:
None
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?: