Evaluation of the regenerative efficacy of Endoret® (PRGF-Plasm Rich in Growth Factors) on the ocular surface of glaucoma patients treated chronically with ocular hypotensive drugs, Evaluación de la eficacia regenerativa de Endoret® (PRGF-Plasma Rico en Factores de Crecimiento) en la superficie ocular de pacientes glaucomatosos tratados de forma crónica con fármacos hipotensores oculares
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tear Osmolarity: It will be measured using the Tearlab® system (a painless collection of a 30-nanoliter tear sample using a microchip with immediate results). The difference in tear osmolarity between V0 and V2 will be evaluated. Tear osmolarity has been selected as the primary variable of the study because its increase (hyperosmolarity) has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.
研究概览
简要总结
To assess the changes in tear osmolarity after topical treatment with PRGF.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with glaucoma who are undergoing treatment with at least two ocular hypotensive drugs (3 drops/day) without preservatives for a minimum of the last two years and who consent to participate in the study.
排除标准
- •Ocular surface pathology other than toxicity due to ocular hypotensive drugs.
- •Previous ocular surface surgeries.
- •Treatment with topical blood derivatives in the last 6 months.
- •Women of childbearing age with pregnancy intention, pregnant women, and breastfeeding women.
- •Allergy to local anesthetics.
结局指标
主要结局
Tear Osmolarity: It will be measured using the Tearlab® system (a painless collection of a 30-nanoliter tear sample using a microchip with immediate results). The difference in tear osmolarity between V0 and V2 will be evaluated. Tear osmolarity has been selected as the primary variable of the study because its increase (hyperosmolarity) has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.
Tear Osmolarity: It will be measured using the Tearlab® system (a painless collection of a 30-nanoliter tear sample using a microchip with immediate results). The difference in tear osmolarity between V0 and V2 will be evaluated. Tear osmolarity has been selected as the primary variable of the study because its increase (hyperosmolarity) has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.
次要结局
未报告次要终点
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau