Evaluation of MAF-1217 in Patients With DED
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Milan, Itália, 20121
- Ospedale San Paolo, ASST Santi Paolo e Carlo
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Milan, Itália, 20157
- ASST Fatebenefratelli Sacco P.O.L. Sacco
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: MAF1217/Cationorm
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The study population will have to self-administer the study treatment in a TID posology.
The study population will have to self-administer the study treatment in a TID posology.
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Experimental: Cationorm/MAF1217
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The study population will have to self-administer the study treatment in a TID posology.
The study population will have to self-administer the study treatment in a TID posology.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Break-up time (BUT) differences
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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Changes in break-up time (BUT) versus baseline
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measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
ocular surface staining (corneal and conjunctival)
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival)
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measured at week 2, 6, 8 and 12 weeks treatment versus baseline
|
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Schirmer I test (ST) (without anesthesia)
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
|
Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia)
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measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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number of blinking per minute
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute
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measured at week 2, 6, 8 and 12 weeks treatment versus baseline
|
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Ferning test (Group D)
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
|
Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)
|
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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osmolarity
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity
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measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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patient satisfaction (10 points VAS scale)
Prazo: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
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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 at week 2, 6, 8 and 12 weeks treatment versus baseline
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OSDI
Prazo: measured at week 2, 6, 8 and 12 weeks treatment
|
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.
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measured at week 2, 6, 8 and 12 weeks treatment
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VF-OS-001/2018
Plano para dados de participantes individuais (IPD)
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