Status:
COMPLETED
Evaluation of MAF-1217 in Patients With DED
Lead Sponsor:
VISUfarma SpA
Conditions:
Evaporative Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 popul...
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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03833882
Start Date
November 27 2018
End Date
June 19 2019
Last Update
July 15 2019
Active Locations (2)
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1
Ospedale San Paolo, ASST Santi Paolo e Carlo
Milan, Italy, 20121
2
ASST Fatebenefratelli Sacco P.O.L. Sacco
Milan, Italy, 20157