RBR-6kkmskk Safety and efficacy on glaucoma treatment with 3 topical medicationsin one bottle x medications in separated bottles

Date of registration: 06/07/2021 ^(mm/dd/yyyy)
Last approval date : 06/07/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Safety and efficacy on glaucoma treatment with 3 topical medicationsin one bottle x medications in separated bottles

  pt-br

  Segurança e eficácia no tratamento do glaucoma com 3 medicações tópicas em um único frasco x medicações em frascos diferentes

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • U1111-1264-7328
    Issuing authority: UTN number
  • 32486920.1.0000.5137
    Issuing authority: Órgão emissor: Plataforma Brasil
  • 4.337.262
    Issuing authority: Órgão emissor: Comitê de Ética em Pesquisa da Pontifícia Universidade Católica de Minas Gerais - PUCMG

Sponsors

• Primary sponsor: centro oftalmologico de minas gerais
• Secondary sponsor:
  • Institution: centro oftalmologico de minas gerais
• Supporting source:
  • Institution: centro oftalmologico de minas gerais

Health conditions

• Health conditions:

  en

  open angle glaucoma

  pt-br

  Glaucoma de ângulo aberto

• General descriptors for health conditions:

• Specific descriptors:

  en

  H40.1 open angle glaucoma

  pt-br

  H40.1 glaucoma de angulo aberto

Interventions

• Interventions:

  en

  There will be included in the study patients with primary open angle glaucoma or ocular hypertension from glaucoma departmet of Centro Oftalmologico hospital. Control group (n=30) was defined as any patient using eyedrops containing 1) prostaglandins (travoprost or bimatoprost) + 2) beta-blockers (timolol maleate 0,5%) + 3) carbonic anhidrase inhibitor (dorzolamide or brinzolamide) ou 3) alpha-agonist (brimonidine taratarate) respecting the inclusion criterias. Intervencionist group (n=30) will have the eyedrops switched to Triplenex. Patients included in the study will be approached one each time by na organized team in a specific room and will be told and guided through the study objective, reasons to be selected to participate, how it will work the random selection in each group of the study, risks and benefits from participating in the study. All patients included will be submited to a comprehensive ophthalmic examination having their best visual acuity measured, bimoicroscopy, intra ocular pressure with Goldman tonometry, central corneal thickness measurement, gonioscopy with Zeiss lens, fundus biomicroscopy for optic nerve assessment and cup/disc evaluation and Humphrey visual field test. Besides that, everyone will have their temporal conjunctiva photographed for objective hyperemia evaluation. Follow up will be every 4 weeks for a total of 12 weeks. Major parameters analysed will be intra ocular pressure and hyperemia through photographs. Patients will be asked about correct use of eyedrops and possible adverse reactions. At the end of the study, comprehensive ophthalmic exam will be done. Comparative analysis of intra ocular pressure and hyperemia will be done between control and interventional group There will be included in the study patients with primary open angle glaucoma or ocular hypertension from glaucoma departmet of Centro Oftalmologico hospital. Control group was defined as any patient using eyedrops containing 1) prostaglandins (travoprost or bimatoprost) + 2) beta-blockers (timolol maleate 0,5%) + 3) carbonic anhidrase inhibitor (dorzolamide or brinzolamide) ou 3) alpha-agonist (brimonidine taratarate) respecting the inclusion criterias. Intervencionist group will have the eyedrops switched to Triplenex. Patients included in the study will be approached one each time by na organized team in a specific room and will be told and guided through the study objective, reasons to be selected to participate, how it will work the random selection in each group of the study, risks and benefits from participating in the study. All patients included will be submited to a comprehensive ophthalmic examination having their best visual acuity measured, bimoicroscopy, intra ocular pressure with Goldman tonometry, central corneal thickness measurement, gonioscopy with Zeiss lens, fundus biomicroscopy for optic nerve assessment and cup/disc evaluation and Humphrey visual field test. Besides that, everyone will have their temporal conjunctiva photographed for objective hyperemia evaluation. Follow up will be every 4 weeks for a total of 12 weeks. Major parameters analysed will be intra ocular pressure and hyperemia through photographs. Patients will be asked about correct use of eyedrops and possible adverse reactions. At the end of the study, comprehensive ophthalmic exam will be done. Comparative analysis of intra ocular pressure and hyperemia will be done between control and interventional group There will be included in the study patients with primary open angle glaucoma or ocular hypertension from glaucoma departmet of Centro Oftalmologico hospital. Control group was defined as any patient using eyedrops containing 1) prostaglandins (travoprost or bimatoprost) + 2) beta-blockers (timolol maleate 0,5%) + 3) carbonic anhidrase inhibitor (dorzolamide or brinzolamide) ou 3) alpha-agonist (brimonidine taratarate) respecting the inclusion criterias. Intervencionist group will have the eyedrops switched to Triplenex. Patients included in the study will be approached one each time by na organized team in a specific room and will be told and guided through the study objective, reasons to be selected to participate, how it will work the random selection in each group of the study, risks and benefits from participating in the study. All patients included will be submited to a comprehensive ophthalmic examination having their best visual acuity measured, bimoicroscopy, intra ocular pressure with Goldman tonometry, central corneal thickness measurement, gonioscopy with Zeiss lens, fundus biomicroscopy for optic nerve assessment and cup/disc evaluation and Humphrey visual field test. Besides that, everyone will have their temporal conjunctiva photographed for objective hyperemia evaluation. Follow up will be every 4 weeks for a total of 12 weeks. Major parameters analysed will be intra ocular pressure and hyperemia through photographs. Patients will be asked about correct use of eyedrops and possible adverse reactions. At the end of the study, comprehensive ophthalmic exam will be done. Comparative analysis of intra ocular pressure and hyperemia will be done between control and interventional group There will be included in the study patients with primary open angle glaucoma or ocular hypertension from glaucoma departmet of Centro Oftalmologico hospital. Control group was defined as any patient using eyedrops containing 1) prostaglandins (travoprost or bimatoprost) + 2) beta-blockers (timolol maleate 0,5%) + 3) carbonic anhidrase inhibitor (dorzolamide or brinzolamide) ou 3) alpha-agonist (brimonidine taratarate) respecting the inclusion criterias. Intervencionist group will have the eyedrops switched to Triplenex. Patients included in the study will be approached one each time by na organized team in a specific room and will be told and guided through the study objective, reasons to be selected to participate, how it will work the random selection in each group of the study, risks and benefits from participating in the study.All patients included will be submited to a comprehensive ophthalmic examination having their best visual acuity measured, bimoicroscopy, intra ocular pressure with Goldman tonometry, central corneal thickness measurement, gonioscopy with Zeiss lens, fundus biomicroscopy for optic nerve assessment and cup/disc evaluation and Humphrey visual field test. Besides that, everyone will have their temporal conjunctiva photographed for objective hyperemia evaluation.Follow up will be every 4 weeks for a total of 12 weeks. Major parameters analysed will be intra ocular pressure and hyperemia through photographs. Patients will be asked about correct use of eyedrops and possible adverse reactions. At the end of the study, comprehensive ophthalmic exam will be done. Comparative analysis of intra ocular pressure and hyperemia will be done between control and interventional group.

  pt-br

  Serão incluídos no estudo pacientes de GPAA e/ou HO atendidos no Departamento de Glaucoma do Hospital Centro Oftalmológico de Minas Gerais. Grupo controle (n=30) foi definido como qualquer paciente que esteja usando colírios a base de 1)prostaglandina (travoprosta ou bimatoprosta) + 2)betabloqueadores (maleato de timolol 0,5%) + 3) inibidores de anidrase carbônica (dorzolamida ou brinzolanida) ou 3)alfa-agonista (tartarato de brimonidina), respeitando os critérios de inclusão. O grupo intervencionista (n=30) terá as medicações citadas no grupo controle substituídas por Triplenex. Os pacientes incluídos no estudo serão abordados, um de cada vez, por uma equipe específica em uma sala pré definida, no dia de consulta de controle sendo orientados sobre o objetivo do estudo;sobre o porque dele ter sido escolhido a participar, como funciona a alocação aleatória em cada grupo; os possíveis riscos e benefícios em utilizar uma nova medicação. Todos os pacientes incluídos no estudo serão submetidos a exame oftalmológico completo incluindo medida da acuidade visual com a melhor correção, biomicroscopia, tonometria de aplanação de Goldman, medida da espessura corneana com paquimetro, gonioscopia com lente 4 espelhos de indentação (Zeiss), biomicroscopia de fundo com documentação da relação E/D e campimetria (Octopus 123). Além disso, todos os pacientes terão a conjuntiva temporal do olho com maior PIO fotografado para avaliação objetiva da hiperemia ocular. O acompanhamento será de 12 semanas ao todo ocorrendo visitas nos meses 1, 2 e 3 e os principais parâmetros analisados serão a PIO e a hiperemia através de fotografias. O paciente será interrogado a respeito do uso correto das medicações oculares (aderência) e de possíveis efeitos adversos observados. Ao término do estudo será feito exame oftalmológico completo à semelhança do realizado no início. Será feito análise comparativa dos parâmetros pressão ocular e hiperemia entre os grupos controle e aqueles submetidos ao Triplenex.

• Descriptors:

  en

  29770 treatment outcome

  pt-br

  29770 resultado do tratamento clinico

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 07/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	-	17 Y	0

• Inclusion criteria:

  en

  18 years of age minimum; ocular hypertension with intraocular pressure levels greater than or equal to 21 mmHg; carrier of open angle glaucoma presenting intraocular pressure levels greater than or equal to 18 mmHg; reduction of intraocular pressure in relation to baseline values ​​<30%; patients intolerant of current treatment due to ocular surface symptoms; meet the criteria of the control group for at least 3 months;

  pt-br

  maiores de 18 anos de idade; atender os critérios do grupo controle por pelo menos 3 meses; hipertenso ocular apresentando níveis de pressão intraocular maior ou igual a 21 mmHg; portador de glaucoma primário de angulo aberto apresentando níveis de pressão intraocular maior ou igual a 18 mmHg; redução da pressão intraocular em relação aos valores basais < 30%; pacientes intolerantes ao tratamento atual devido à sintomas de superfície ocular

• Exclusion criteria:

  en

  monoaminoxidase users; patients with asthma or severe chronic obstructive pulmonary disease; patients with sinus bradycardia, atrioventricular block of 2 or 3 degrees not controlled with a pacemaker, decompensated congestive heart failure; patient known to be allergic to any of the components of TRIPLENEX; pregnant patients; patients with any corneal irregularity that hinder the perfect reading of intraocular pressure by Goldman's tonometer (intra stromal ring, corneal transplant or scars with important corneal thinning); patients undergoing anti-glaucoma surgical procedures in the last 3 months (laser trabeculoplasty; incisional procedures such as trabeculectomy; glaucoma drainage devices, among others)

  pt-br

  usuários de monoaminoxidase; portadores de asma ou doença pulmonar obstrutiva crônica grave; portadores de bradicardia sinusal, bloqueio atrioventricular de 2 ou 3 grau não controlado com marcapasso, insuficiência cardiaca congestiva descompensada; paciente sabidamente alérgico a algum dos componentes da medicação combinada em um único frasco (bimatoprosta 0,1mg/ml + tartarato de brimonidina 1,5mg/ml + maleato de timolol 6,83 mg/mL); pacientes grávidas; pacientes que apresentem qualquer irregularidade corneana que dificultem a perfeita leitura da pressão intraocular pelo tonômetro de Goldman (anel intra estromal, transplante de córnea ou cicatrizes com afinamento corneano importante); pacientes submetidos a procedimentos cirúrgicos antiglaucomatosos nos últimos 3 meses (trabeculoplastia a laser ou procedimentos incisionais como trabeculectomia, implantes de drenagem,entre outros)

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Evaluate IOP reduction in TRIPLENEX group when compared to control group through t student test ( comparing the mean between groups). We decided to use significance level of 0,05% and 90 % of power. IOP values more than 2.52 mmHg between groups will be considered statistical significance taking into account a calculated effect of 85 % for the study

  pt-br

  Avaliar a redução da PIO no grupo TRIPLENEX em comparação ao grupo controle através de T student test ( comparação entre as médias entre os dois grupos). Optamos por usar um nível de significância de 0,05% e um poder de 90%. Valores de 2.52 mmHg de diferença entre os grupos será considerado estatisticamente significativo levando-se em conta um efeito calculado para o experimento de 85%

• Secondary outcomes:

  en

  Evaluate whether with the use of TRIPLENEX there is a change in the symptoms of ocular surface disease through the application of the OSDI questionnaire (ocular surface disease index)

  pt-br

  Avaliar se com o uso do TRIPLENEX há alteração nos sintomas de doença da superfície ocular através da aplicação do questionário IDSO (índice de doença da superfície ocular)

Contacts

• Public contact
  • Full name: Cláudio Gonçalves Ramos da Silva
  • • Address: Av Lucio Costa n 6200 ap 603
    • City: Rio de Janeiro / Brazil
    • Zip code:
  • Phone: +55 21 965149915
  • Email: claudioramosmd@gmail.com
  • Affiliation:
   
• Scientific contact
  • Full name: Gustavo Muradas San Martin Reis
  • • Address: Rua Santa Catarina 941
    • City: Belo Horizonte / Brazil
    • Zip code:
  • Phone: +55-31-984461221
  • Email: gustavo_muradas@hotmail.com
  • Affiliation:
   
• Site contact
  • Full name: Gustavo Muradas San Martin Reis
  • • Address: Rua Santa Catarina 941
    • City: Belo Horizonte / Brazil
    • Zip code:
  • Phone: +55-31-984461221
  • Email: gustavo_muradas@hotmail.com
  • Affiliation:
   

Additional links:

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