Topical Tacrolimus in Vernal Keratoconjunctivitis
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
- 否
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
20 eyes with active Vernal Keratoconjunctivitis
干预措施: Topical tacrolimus (Drug)
Placebo
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
Samir S. Shoughy, MD, FRCS (Glasg.)
Ophthalmologist
The Eye Center and The Eye Foundation for Research in Ophthalmology
