Evaporative Dry Eye Disease Clinical Trial
Official title:
Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study
comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED.
The study population will be divided in 4 different subgroups, according to the different
types of evaporative DED:
1. Group A: high evaporative levels
2. Group B: females in menopause, whether using hormonal integration or not
3. Group C: presence of active obstructive Meibomian gland disease
4. Group D: glaucomatous patients
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04521465 -
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye
|
||
Completed |
NCT03843983 -
Effect of Thermal Pulsation System (Lipiflow) Treatment for Ocular Surface Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Completed |
NCT03956225 -
Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
|
N/A | |
Completed |
NCT02004067 -
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
|
Phase 4 | |
Completed |
NCT06242860 -
Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease
|
N/A |