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临床试验/NCT00827255
NCT00827255已完成不适用

Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

Allergan0 个研究点目标入组 35 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Allergan
入组人数
35
主要终点
Percentage of Patients With Complete Clearing of Corneal Staining at Month 12

研究概览

简要总结

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Adults >16 years of age
  • Dry eye patients
  • Subject with history of less than 12 weeks of initial RESTASIS® treatment
  • Subject started second trial of RESTASIS® treatment prior to June 1, 2008
  • First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

排除标准

  • Patients with Contact Lens Intolerance
  • Patients with Ocular Rosacea

研究组 & 干预措施

Patients who received Restasis®

Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)

干预措施: Cyclosporine Ophthalmic Emulsion 0.05% (Drug)

结局指标

主要结局

Percentage of Patients With Complete Clearing of Corneal Staining at Month 12

时间窗: Month 12

Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.

次要结局

  • Schirmer's Test at Month 12(Month 12)

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

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