Sovesudil (locally acting rho kinase inhibitor) for the treatment of normal-tension glaucoma: the randomized phase II study.
Acta Ophthalmol
; 100(2): e470-e477, 2022 Mar.
Article
en En
| MEDLINE
| ID: mdl-34318607
ABSTRACT
PURPOSE:
To evaluate ocular hypotensive efficacy and the safety of sovesudil (formally known as PHP-201), a novel Rho-associated protein kinase (ROCK) inhibitor, in patients with normal-tension glaucoma (NTG).DESIGN:
Multicentre, prospective, double-masked, randomized, placebo-controlled, parallel clinical study.METHODS:
Patients with NTG (unmedicated baseline IOP ≤ 21 mmHg) were randomized in 3 groups and treated with sovesudil in concentrations of 0.25% and 0.5%, or with a placebo three times daily (TID) for 4 weeks. The primary end-point was the mean diurnal IOP change from the baseline at week 4. Safety was recorded over a 4-week treatment period and the following 2-week observation period.RESULTS:
A total of 119 patients were included in the primary efficacy analysis. The mean diurnal IOP change from the baseline at week 4 was -1.56 mmHg for the high-dose group, -1.10 mmHg for the low-dose group and -0.65 mmHg for the placebo group. The difference between the high-dose and the placebo groups was -0.91 mmHg (95% confidence intervals -1.73, -0.09). 0.5% sovesudil TID met the criteria for superiority to the placebo. The most frequent ocular adverse event among sovesudil-treated patients was conjunctival hyperaemia (24.4% for the high-dose and 17.5% for the low-dose group) and predominately classified as mild.CONCLUSIONS:
Sovesudil 0.25% and 0.5% TID showed statistically significant IOP-lowering effects and 0.5% concentration's IOP-lowering effects met the superiority criteria in comparison with the placebo at week 4. Sovesudil was well tolerated with mild adverse events including relatively low incidence of conjunctival hyperaemia in patients with NTG.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Quinasas Asociadas a rho
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Glaucoma de Baja Tensión
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Presión Intraocular
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Acta Ophthalmol
Asunto de la revista:
OFTALMOLOGIA
Año:
2022
Tipo del documento:
Article
Pais de publicación:
ENGLAND
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ESCOCIA
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GB
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GREAT BRITAIN
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INGLATERRA
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REINO UNIDO
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SCOTLAND
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UK
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UNITED KINGDOM