drugset / Trial / NCT06868745
Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
RandomizedParallel-groupTriple-blindSupportive care
Summary
A prospective, randomized, parallel, crossover, double-blind therapeutic clinical trial was conducted in accordance with the principles of the Resolution nº 466/12 of the National Health Council and was approved by the Ethics and Research Committee of the Federal University of São Paulo, project CEP/UNIFESP n:1023/2020, CAAE: 36946620.9.0000.5505. Written informed consent was obtained from all participants. The study was conducted at the Glaucoma Division and the Department of Psychobiology at the Federal University of São Paulo - UNIFESP/EPM and at the Laser Vision Eye Hospital - Santos/SP between May/2022 and July/2023.
Timeline
- Start
- 2022-05-04
- Primary completion
- 2023-07-20
- Completion
- 2024-06-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 5 mg | — |