Evaluation of MAF-1217 in Patients With DED

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Evaporative Dry Eye Disease

Intervention / Treatment
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* Device: MAF1217
* Other: Cationorm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAF1217/Cationorm<br> | Device: MAF1217<br>* The study population will have to self-administer the study treatment in a TID posology.<br>Other: Cationorm<br>* The study population will have to self-administer the study treatment in a TID posology.<br>|
| Experimental: Cationorm/MAF1217<br> | Device: MAF1217<br>* The study population will have to self-administer the study treatment in a TID posology.<br>Other: Cationorm<br>* The study population will have to self-administer the study treatment in a TID posology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Break-up time (BUT) differences | Changes in break-up time (BUT) versus baseline | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular surface staining (corneal and conjunctival) | Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival) | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| Schirmer I test (ST) (without anesthesia) | Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia) | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| number of blinking per minute | Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| Ferning test (Group D) | Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D) | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| osmolarity | Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| patient satisfaction (10 points VAS scale) | Cross-over analysis for the differences versus baseline between the two groups on changes in patient satisfaction (10 points VAS scale). (VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level). | measured at week 2, 6, 8 and 12 weeks treatment versus baseline | 
| OSDI | Changes in questionnaire scores (OSDI - Ocular Surface Disease Index). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | measured at week 2, 6, 8 and 12 weeks treatment |