NCT03833882

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

January 31, 2019

Last Update Submit

July 12, 2019

Conditions

Evaporative Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • ocular surface staining (corneal and conjunctival)

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

  • Schirmer I test (ST) (without anesthesia)

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

  • number of blinking per minute

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

  • Ferning test (Group D)

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

  • osmolarity

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

  • +2 more secondary outcomes

Study Arms (2)

MAF1217/Cationorm

EXPERIMENTAL
Device: MAF1217Other: Cationorm

Cationorm/MAF1217

EXPERIMENTAL
Device: MAF1217Other: Cationorm

Interventions

MAF1217DEVICE

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

Cationorm/MAF1217MAF1217/Cationorm
CationormOTHER

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

Cationorm/MAF1217MAF1217/Cationorm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale San Paolo, ASST Santi Paolo e Carlo

Milan, 20121, Italy

Location

ASST Fatebenefratelli Sacco P.O.L. Sacco

Milan, 20157, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32606580DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cationorm

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 7, 2019

Study Start

November 27, 2018

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

IT(2)