RBR-7r2r7n Investigation of adherence to eyedrops in patients with glaucoma

Date of registration: 05/19/2020 ^(mm/dd/yyyy)
Last approval date : 05/19/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1230-8643

• Public title:

  en

  Investigation of adherence to eyedrops in patients with glaucoma

  pt-br

  Investigacao do uso adequado de colirios em pacientes com glaucoma

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 79793517.5.0000.5667
    Issuing authority: Plataforma Brasil
  • 1.616.706
    Issuing authority: Comite de etica e pesquisa

Sponsors

• Primary sponsor: Allergan
• Secondary sponsor:
  • Institution: Allergan
• Supporting source:
  • Institution: Allergan

Health conditions

• Health conditions:

  en

  Glaucoma

  pt-br

  glaucoma

• General descriptors for health conditions:

  en

  H00-H59 VII - Diseases of the eye and adnexa

  pt-br

  H00-H59 VII - Doenças do olho e anexos

• Specific descriptors:

Interventions

• Interventions:

  en

  Questionnaire about barriers regarding the eyedrop usage. Use of eletronic monitoring system devices to monitore eyedrop use. Inclusion of 100 patients.

  pt-br

  Preenchimento de formulário sobre aderência ao tratamento do glaucoma que serve para avaliar quais as dificuldades encontradas pelo paciente no uso do colírios. Uso de dispositivo eletronico para monitorar o uso dos colirios. Inclusão de 100 pacientes.

• Descriptors:

  en

  F01.100.150.750.500.600.500 Medication Adherence

  pt-br

  F01.100.150.750.500.600.500 Adesão à Medicação

  es

  F01.100.150.750.500.600.500 Cumplimiento de la Medicación

  en

  E05.318.308.980 Surveys and Questionnaires

  pt-br

  E05.318.308.980 Inquéritos e Questionários

  es

  E05.318.308.980 Encuestas y Cuestionarios

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 04/24/2018 ^(mm/dd/yyyy)
• Date last enrollment: 10/30/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  100	-	18 Y	99 Y

• Inclusion criteria:

  en

  Will be included in the glaucoma group: patients older than 18 years and one day ; the patients with glaucoma, defined by the presence of optic neuropathy with glaucoma typical changes (optic disc excavation greater than 0.6, optical disc excavation asymmetry greater than 0.2, atrophy of the nerve fiber layer, localized loss of the neuroretinal rhyme) , and with changes in the white to white perimetry examination; patients taking at least one hypotensive eye drop.

  pt-br

  Serão incluídos no grupo glaucoma pacientes com idade superior a 18 anos e um dia; os pacientes com glaucoma, definidos pela presença de neuropatia óptica com alterações típicas de glaucoma (escavação de disco óptico maior que 0,6, assimetria de escavação de disco maior que 0,2, atrofia da camada de fibras nervosas, perda localizada da rima neurorretiniana), juntamente com alterações no exame da perimetria branco no branco; pacientes que façam uso de pelo menos um colírio hipotensor.

• Exclusion criteria:

  en

  Patient under 18 years of age; those who have not yet been diagnosed with confirmed glaucoma; patients unable to respond to the questionnaire applied.

  pt-br

  Paciente menores de 18 anos; aqueles que ainda não tenham diagnóstico de glaucoma confirmado; pacientes incapazes de responder ao questionário aplicado.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Prevention	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  To evaluate objectively adherence treatment of patients with glaucoma using eletronic monitoring system devices

  pt-br

  Avaliar objetivamente a aderência ao tratamento em pacientes com glaucoma atraves do uso de dispositivo eletronico de monitoramento

• Secondary outcomes:

  en

  To identify risk factors associated with non-adherence.

  pt-br

  Identificar fatores de risco para não aderência

Contacts

• Public contact
  • Full name: Ricardo Yuji Abe
  • • Address: SGAS 607
    • City: Brasília / Brazil
    • Zip code: 70200-670
  • Phone: +55-061-998844060
  • Email: ricardoabe85@yahoo.com.br
  • Affiliation: Hospital Oftalmologico de Brasilia
   
• Scientific contact
  • Full name: Ricardo Yuji Abe
  • • Address: SGAS 607
    • City: Brasília / Brazil
    • Zip code: 70200-670
  • Phone: +55-061-998844060
  • Email: ricardoabe85@yahoo.com.br
  • Affiliation: Hospital Oftalmologico de Brasilia
   
• Site contact
  • Full name: Ricardo Yuji Abe
  • • Address: SGAS 607
    • City: Brasília / Brazil
    • Zip code: 70200-670
  • Phone: +55-061-998844060
  • Email: ricardoabe85@yahoo.com.br
  • Affiliation: Hospital Oftalmologico de Brasilia
   

Additional links:

• Download in ICTRP format