Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change of corneal staining from baseline to 6 months after treatment
研究概览
简要总结
This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).
详细描述
Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Dry eye disease diagnosis
- •Treatment with artificial tears or hyaluronic acid gels for at least 3 months
- •Signed informed consent by the patient
- •Staining equal to or greater than Oxford II
排除标准
- •Under 18 years old
- •Corneal staining under Oxford II
- •Treatment for dry eye disease other than artificial tears or hyaluronic acid gels
- •Severe dry eye disease that requires immediate treatment
- •Eye surgery in the last 6 months
- •Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
- •Contact lenses
- •Other treatment besides artificial tears or hyaluronic acid gels
- •Visual acuity less than 0.1
- •Allergy or intolerance to any of the components included in the study
- •Modifications in systemic immunosuppressive treatment
- •Pregnancy or lactation
- •Women of childbearing age who do not use a highly effective contraceptive method
- •History of alcohol or drug abuse
- •Participation in another clinical trial in the last 30 days
- •Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)
研究组 & 干预措施
Insulin
Topical insulin 1UI/ml 4 times a day
干预措施: Insulin (Drug)
Cyclosporin
Cyclosporin 0,05% every 12 hours
干预措施: Cyclosporins (Drug)
Artificial tears
Artificial tears 4 times a day
干预措施: Artificial tears (Drug)
结局指标
主要结局
Change of corneal staining from baseline to 6 months after treatment
时间窗: From baseline to 6 months after treatment
Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)
次要结局
- Changes in dry eye symptoms from baseline to 6 months after treatment time(From baseline to 6 months after treatment)
- Changes in esthesiometry from baseline to 6 months after treatment time(From baseline to 6 months after treatment)
- Changes in tear rupture time from baseline to 6 months after treatment time(From baseline to 6 months after treatment)
研究者
Barbara Burgos Blasco
Ophthalmologist
Hospital San Carlos, Madrid