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O estudo clínico NCT07325240 para Glaucoma de Ângulo Aberto, Hipertensão ocular está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients Fase IV 30
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07325240 procura avaliar tratamento para Glaucoma de Ângulo Aberto, Hipertensão ocular. Este é um estudo intervencionista de Fase IV. Seu status atual é: em recrutamento. O estudo começou em 21 de novembro de 2025 e pretende incluir 30 participantes. Coordenado por a Clínica Maio e deve ser concluído em 1 de outubro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de março de 2026.
Resumo
The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).
Descrição detalhada
This will be a double-masked, paired-contralateral, descriptive study to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT). Study medication will be administered for 14 co...Mostrar mais
Título oficial
24-hour Effect Of Rocklatan Compared With Latanoprost In Open Angle Glaucoma And Ocular Hypertension Patients
Condições médicas
Glaucoma de Ângulo AbertoHipertensão ocularPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- 25-012250
Número NCT
Data de início (real)
2025-11-21
Última atualização postada
2026-03-23
Data de conclusão (estimada)
2027-10
Inscrição (estimada)
30
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Experimentalnetarsudil-latanoprost arm | Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution Subjects will receive netarsudil-latanoprost fixed combination ophthalmic solution 0.02%/0.005% in one eye and compare it to latanoprost 0.005% in the contralateral eye |
Comparador ativolatanoprost arm | Latanoprost 0.005% Ophthalmic Solution latanoprost 0.005% solution will be applied in the contralateral eye, once daily, QD (PM) for 14 days |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in mean Intraocular Pressure (IOP) | Change in mean IOP from baseline at each time point for Latanoprost | Change in mean IOP after 2 weeks of treatment with Latanoprost compared to baseline |
Change in mean IOP | Change in mean IOP from baseline at each time point for Rocklatan | Change in mean IOP after 2 weeks of treatment with Rocklatan compared to baseline |
Change in mean IOP | Change in mean IOP from Latanoprost at each time point for Rocklatan | Change in mean IOP from baseline after 2 weeks of treatment with latanoprost minus change in mean IOP from baseline after 2 weeks of treatment with Rocklatan |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in mean nocturnal IOP | Change in mean nocturnal IOP (both absolute and % change) from baseline for Latanoprost | Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Latanoprost compared to baseline |
Change in mean nocturnal IOP | Change in mean nocturnal IOP (both absolute and % change) from baseline for Rocklatan | Mean nocturnal IOP will be calculated based on the time points during the sleeping hours (11 PM - 7 AM) after 2 weeks of treatment with Rocklatan compared to baseline |
Change in mean diurnal IOP | Change in mean diurnal IOP (both absolute and % change) from baseline for Latanoprost | Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Latanoprost compared to baseline |
Change in mean diurnal IOP | Change in mean diurnal IOP (both absolute and % change) from baseline for Rocklatan | Mean diurnal IOP will be calculated based on the time points during the sleeping hours (7 AM - 11 PM) after 2 weeks of treatment with Rocklatan compared to baseline |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus examination within one year of the screening visit.
- Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit
- Be able and willing to provide signed informed consent and follow study instructions
- Ability to cooperate with the examinations required for the study and be able to attend all study visits
- If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits.
- Best-corrected visual acuity (BCVA) using ETDRS chart of +0.4 logMAR units (Snellen equivalent ~ 20/50) or better in each eye
Ocular:
- Subjects with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral iridotomy in either eye
- Severe glaucomatous damage
- Difference in IOP between eyes > 4 mmHg (unmedicated) at any baseline time point
- Use of more than two ocular hypotensive medications within 30 days of screening
- Chronic or recurrent inflammatory eye diseases in either eye
- Ocular infection or ocular inflammation in the past 3 months in either eye
- Ocular trauma other than corneal abrasion within the past 6 months in either eye
- Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration, macular edema, retinal vein or artery occlusion) in either eye
- Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, keratoconus) in either eye
- Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye
- Central corneal thickness less than 480 μm or greater than 620 μm in either eye
- Previous intraocular surgery other than routine uncomplicated cataract surgery in either eye
- Previous glaucoma intraocular surgery or glaucoma laser procedures (except SLT performed more than 6 months ago) in either eye
- Unilateral intraocular surgery or glaucoma laser procedures
- Previous corneal refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking, etc.)
- Severe dry eye in either eye
- Use of ocular medications in either eye within 30 days of screening, with the exception of IOP-lowering medications (which must be washed out according to the provided schedule), and lubricating drops for dry eye (which may be used throughout the study)
- Known hypersensitivity to any component of the formulation (eg, benzalkonium chloride, etc.), or to topical anesthetic
Systemic:
- Clinically significant systemic diseases which might interfere with the study
- Participation in any interventional study within 30 days prior to screening visit
- Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study including, β-adrenergic antagonists, α-adrenergic agonists and antagonists, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers
- Recent change in medications that are known to affect IOP within 30 days prior to the screening visit and during the study including: systemic/inhaled steroids, calcium channel blockers, diuretics, and vasodilators
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative pregnancy test result at the screening examination and must not intend to become pregnant during the study
- Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
Responsável pelo estudo
Arthur J. Sit, M.D., Investigador principal, Principal Investigator, Mayo Clinic
Contato central do estudo
Contato: Bridgette Halder, 507-422-2780, [email protected]
1 Locais do estudo em 1 países
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Bridgette Halder, Contato, 507-422-2780
Arthur J Sit, MD, MS, Investigador principal
Em recrutamento