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Evaluation of MAF-1217 in Patients With DED

Primary Purpose

Evaporative Dry Eye Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

MAF1217

Cationorm

About this trial

This is an interventional treatment trial for Evaporative Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ospedale San Paolo, ASST Santi Paolo e Carlo
ASST Fatebenefratelli Sacco P.O.L. Sacco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MAF1217/Cationorm

Cationorm/MAF1217

Arm Description

Outcomes

Primary Outcome Measures

Break-up time (BUT) differences

Changes in break-up time (BUT) versus baseline

Secondary Outcome Measures

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)

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)

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

Ferning test (Group D)

Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)

osmolarity

Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity

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).

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.

Full Information

NCT ID

NCT03833882

First Posted

January 31, 2019

Last Updated

July 12, 2019

Sponsor

VISUfarma SpA

1. Study Identification

Unique Protocol Identification Number

NCT03833882

Brief Title

Evaluation of MAF-1217 in Patients With DED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 27, 2018 (Actual)

Primary Completion Date

June 19, 2019 (Actual)

Study Completion Date

June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VISUfarma SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Evaporative Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAF1217/Cationorm

Arm Type

Experimental

Arm Title

Cationorm/MAF1217

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

MAF1217

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Cationorm

Intervention Description

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

Primary Outcome Measure Information:

Title

Break-up time (BUT) differences

Description

Changes in break-up time (BUT) versus baseline

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Secondary Outcome Measure Information:

Title

ocular surface staining (corneal and conjunctival)

Description

Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival)

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

Schirmer I test (ST) (without anesthesia)

Description

Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia)

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

number of blinking per minute

Description

Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

Ferning test (Group D)

Description

Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

osmolarity

Description

Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

patient satisfaction (10 points VAS scale)

Description

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Title

OSDI

Description

Time Frame

measured at week 2, 6, 8 and 12 weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Ospedale San Paolo, ASST Santi Paolo e Carlo

City

Milan

ZIP/Postal Code

20121

Country

Italy

Facility Name

ASST Fatebenefratelli Sacco P.O.L. Sacco

City

Milan

ZIP/Postal Code

20157

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32606580

Citation

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.

Results Reference

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Evaluation of MAF-1217 in Patients With DED

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