Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Evaporative Dry Eye Disease
- Sponsor
- VISUfarma SpA
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Break-up time (BUT) differences
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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)
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- patient satisfaction (10 points VAS scale)(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)
- OSDI(measured at week 2, 6, 8 and 12 weeks treatment)