2024-518407-22-00招募中4 期
Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors
Hospital Clinico San Carlos, Hospital Clinico San Carlos1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in dry eye symptoms from baseline to 6 months after treatment time
研究概览
简要总结
The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).
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
- •Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
- •Patients ≥ 18 years at the screening visit.
- •Ocular hypertension or glaucoma controlled with hypotensive treatment
- •Diagnosis of dry eye
排除标准
- •Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
- •Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
- •Modifications in systemic immunosuppressive treatment in the last 6 months
- •History of alcohol or drug abuse
- •Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
- •Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
- •Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.
- •Changes in topical glaucoma treatment in the last 3 months
- •Severe dry eye requiring immediate treatment
- •Previous eye surgery, except cataract surgery more than 12 months ago
- •Laser procedures less than 6 months ago
- •Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
- •Eyelid disorders
- •Use of contact lenses
- •Other topical treatment other than dry eye and glaucoma
结局指标
主要结局
Changes in dry eye symptoms from baseline to 6 months after treatment time
Changes in dry eye symptoms from baseline to 6 months after treatment time
次要结局
- Change of corneal staining from baseline to 6 months after treatment
- Change in corneal aesthesiometry from baseline to 6 months after treatment
- Change in conjunctival hyperemia from baseline to 6 months after treatment
- Change in non-invasive tear film break-up time from baseline to 6 months after treatment
- Change in light dispersion from baseline to 6 months after treatment
- Change in cytokine levels from baseline to 6 months after treatment
- Changes in therapeutic compliance with hypotensive treatment
- Proportion of patients presenting adverse effects
研究者
Barbara Burgos Blasco
Scientific
Hospital Clinico San Carlos
研究点 (1)
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