Evaluation of MAF-1217 in Patients With DED

VISUfarma

Status

Completed

Conditions

Evaporative Dry Eye Disease

Treatments

Other: Cationorm

Device: MAF1217

Study type

Interventional

Funder types

Industry

Identifiers

NCT03833882

VF-OS-001/2018

Details and patient eligibility

About

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:

Group A: high evaporative levels
Group B: females in menopause, whether using hormonal integration or not
Group C: presence of active obstructive Meibomian gland disease
Group D: glaucomatous patients

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 18 years old (adult patients), male and female
Schirmer I test > 10 mm at 5'
(Group A): high evaporative levels
(Group B): females in menopause, both using hormonal integration or not
(Group C): presence of active obstructive Meibomian gland disease, defined as at least one of the following:
- Meibomian orifice plugging
- eyelid margin foaminess
- changes in orifice position with respect to the mucocutaneous junction
- abnormal Meibomian gland secretions (opaque and viscous-like form that is difficult to express)
(Group D): glaucomatous patients receiving one or more BAK preserved treatments for at least 2 years, showing an abnormal Ferning test (Types 3 or 4 according to Rolando)
all: wishing to participate in the study and able to sign the ICF

Inclusion criteria to be checked at baseline:

BUT < 7"
Mild to severe DED according to OSDI chart

Exclusion criteria

Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
Coexisting corneal diseases
Autoimmune diseases
Past or active cicatricial conjunctivitis
Past ocular surface burns
Keratinization of the eyelid margin
Sjogren syndrome
History of corneal trauma
Pregnant and lactating women
Younger than 18 years old patients
Use of contact lenses
inability to self administer study medications
(GROUPS B, D) Presence of active obstructive Meibomian gland disease
(GROUP C) Presence of cicatricial Meibomian gland disease
known allergic sensitivity to any of the devices ingredients or any other known allergy
participation in a clinical trial during the 3 months prior to the beginning of the study