Evaluation of MAF-1217 in Patients With DED

NCT ID: NCT03833882

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-06-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MAF1217/Cationorm

Group Type: EXPERIMENTAL

MAF1217

Intervention Type: DEVICE

The study population will have to self-administer the study treatment in a TID posology.

Cationorm

Intervention Type: OTHER

The study population will have to self-administer the study treatment in a TID posology.

Cationorm/MAF1217

Group Type: EXPERIMENTAL

MAF1217

Intervention Type: DEVICE

The study population will have to self-administer the study treatment in a TID posology.

Cationorm

Intervention Type: OTHER

The study population will have to self-administer the study treatment in a TID posology.

Interventions

MAF1217

The study population will have to self-administer the study treatment in a TID posology.

Intervention Type: DEVICE

Cationorm

The study population will have to self-administer the study treatment in a TID posology.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. At least 18 years old (adult patients), male and female

2. Schirmer I test > 10 mm at 5'

3. (Group A): high evaporative levels

4. (Group B): females in menopause, both using hormonal integration or not

5. (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)

6. (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)

7. all: wishing to participate in the study and able to sign the ICF

1. BUT < 7"

2. Mild to severe DED according to OSDI chart

Exclusion Criteria

1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)

2. Coexisting corneal diseases

3. Autoimmune diseases

4. Past or active cicatricial conjunctivitis

5. Past ocular surface burns

6. Keratinization of the eyelid margin

7. Sjogren syndrome

8. History of corneal trauma

9. Pregnant and lactating women

10. Younger than 18 years old patients

11. Use of contact lenses

12. inability to self administer study medications

13. (GROUPS B, D) Presence of active obstructive Meibomian gland disease

14. (GROUP C) Presence of cicatricial Meibomian gland disease

15. known allergic sensitivity to any of the devices ingredients or any other known allergy

16. participation in a clinical trial during the 3 months prior to the beginning of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VISUfarma SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale San Paolo, ASST Santi Paolo e Carlo

Milan, , Italy

ASST Fatebenefratelli Sacco P.O.L. Sacco

Milan, , Italy

Countries

Italy

References

Fogagnolo P, Quisisana C, Caretti A, Marchina D, Dei Cas M, Melardi E, Rossetti L. Efficacy and Safety of VisuEvo(R) and Cationorm(R) for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial. Clin Ophthalmol. 2020 Jun 18;14:1651-1663. doi: 10.2147/OPTH.S258081. eCollection 2020.

Reference Type: DERIVED

PMID: 32606580 (View on PubMed)

Other Identifiers

VF-OS-001/2018

Identifier Type: -

Identifier Source: org_study_id