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临床试验/NCT02456025
NCT02456025Unknown4 期

Topical Tacrolimus in Vernal Keratoconjunctivitis

The Eye Center and The Eye Foundation for Research in Ophthalmology1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
20
试验地点
1
主要终点
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis

研究概览

简要总结

The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

详细描述

A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.

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, Investigator)

入排标准

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

入选标准

  • with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
  • Patients 6-18 years of age

排除标准

  • Pregnant patients
  • Patients on systemic therapy for other allergic disorders
  • Patients who cannot come for follow-up
  • Patients who are on other topical medications for other comorbid ocular conditions

研究组 & 干预措施

Topical tacrolimus

Active Comparator

20 eyes with active Vernal Keratoconjunctivitis

干预措施: Topical tacrolimus (Drug)

Placebo

Placebo Comparator

20 eyes with active Vernal Keratoconjunctivitis

干预措施: Topical tacrolimus (Drug)

结局指标

主要结局

The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis

时间窗: Five months

To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction

次要结局

未报告次要终点

研究者

发起方
The Eye Center and The Eye Foundation for Research in Ophthalmology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samir S. Shoughy, MD, FRCS (Glasg.)

Ophthalmologist

The Eye Center and The Eye Foundation for Research in Ophthalmology

研究点 (1)

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