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临床试验/NCT04637633
NCT04637633已完成2 期

Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis

Farwaniya Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Epiphora grading

研究概览

简要总结

to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis

详细描述

a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of either sex
  • had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
  • grade 0 punctal stenosis
  • did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.

排除标准

  • congenital punctal obstruction
  • edematous puncti
  • allergic conjunctivitis
  • history of dacryocystitis,
  • inflammatory systemic diseases
  • any previous chemotherapy treatment, and local irradiation.
  • other causes of epiphora, lid laxity, entropion, and ectropion
  • lid malposition, canalicular or nasolacrimal sac or duct obstruction
  • previous eyelid or lacrimal drainage surgery
  • untreated conjunctivitis or blepharitis

研究组 & 干预措施

Cyclosporine A

Experimental

All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.

干预措施: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose, (Drug)

结局指标

主要结局

Epiphora grading

时间窗: 3 months

Munk grading system score from 0 to 5 the higher the worse

次要结局

  • Fluorescein dye disappearance test (FDT)(3 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mona A Nassief

lecturer of ophthalmology Mansoura University Egypt currentlty working as senior registrar in Farwaniya Hospital

Farwaniya Hospital

研究点 (1)

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