Evaporative Dry Eye DiseaseNCT03833882
Evaluation of MAF-1217 in Patients With DED
A study testing MAF1217 and Cationorm in people with Evaporative Dry Eye Disease, run by VISUfarma SpA at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaporative Dry Eye Disease
- What is being tested?
- MAF1217 and Cationorm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesItaly
- Study dates
- 27 Nov 2018to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale San Paolo, ASST Santi Paolo e Carlo
Milan, 20121
ASST Fatebenefratelli Sacco P.O.L. Sacco
Milan, 20157
About this study
Official title: Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
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
Read the 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
- Being tested
- MAF1217, Cationorm
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAF1217Device
The study population will have to self-administer the study treatment in a TID posology.
CationormOther
The study population will have to self-administer the study treatment in a TID posology.
| Study group | Role | What they receive |
|---|---|---|
| MAF1217/Cationorm | Experimental | Not described Receives: Device: MAF1217; Other: Cationorm |
| Cationorm/MAF1217 | Experimental | Not described Receives: Device: MAF1217; Other: Cationorm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Break-up time (BUT) differences
Changes in break-up time (BUT) versus baseline
Measured: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Secondary outcomes (7)
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: 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: 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: 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: 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: 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: 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: measured at week 2, 6, 8 and 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start27 Nov 2018
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaporative Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833882
- Sponsor's protocol ID
- VF-OS-001/2018
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32606580
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
- ClinicalTrials.gov ID
- NCT03833882
- Acronym / sponsor ID
- VF-OS-001/2018
- Conditions
- Evaporative Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAF1217/Cationorm | Experimental | Device: MAF1217, Other: Cationorm |
| Cationorm/MAF1217 | Experimental | Device: MAF1217, Other: Cationorm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAF1217The study population will have to self-administer the study treatment in a TID posology. | Device | Cationorm/MAF1217, MAF1217/Cationorm |
| CationormThe study population will have to self-administer the study treatment in a TID posology. | Other | Cationorm/MAF1217, MAF1217/Cationorm |
Primary outcome
Break-up time (BUT) differences
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Changes in break-up time (BUT) versus baseline
7 secondary outcomes
ocular surface staining (corneal and conjunctival)
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Schirmer I test (ST) (without anesthesia)
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
number of blinking per minute
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Ferning test (Group D)
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
osmolarity
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
patient satisfaction (10 points VAS scale)
Time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
OSDI
Time frame: measured at week 2, 6, 8 and 12 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 32606580Fogagnolo 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.
- Individual participant dataSharing planned: Undecided
Related trials for Evaporative Dry Eye Disease
Not yet recruitingPhase 4
Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAF1217 and Cationorm in people with Evaporative Dry Eye Disease, run by VISUfarma SpA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Break-up time (BUT) differences (time frame: measured at week 2, 6, 8 and 12 weeks treatment versus baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.