NCT03833882

Evaluation of MAF-1217 in Patients With DED

Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Evaporative Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	MAF1217	The study population will have to self-administer the study treatment in a TID posology.
OTHER	Cationorm	The study population will have to self-administer the study treatment in a TID posology.

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2019-02-07
• Last updated: 2019-07-15

Locations

2 sites across 1 country: Italy