Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Goblet cell density
研究概览
简要总结
a randomized, investigator-blind, interventinal study will compare the effect of benzalkonium-chloride (BAK) preserved and preservative-free (PF) eye drops on conjunctival goblet cells.
详细描述
The investigators will conduct a randomized, investigator-blind, interventinal study on 28 subjects. Each subject will apply a benzalkonium-chloride (BAK) preserved eye drop (Xalatan) in one eye and a preservative-free (PF) eye drop (Monoprost) in the other for 3 months. Which eye gets which treatment is randomized. Before and after treatment a conjunctival print will be made and the effect of the eye drops on goblet cell density will be evaluated along with effect on the intraocular pressure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18years
- •Danish speaking
- •Open angle glaucoma or ocular hypertension
- •Average intraocular pressure equal to or above 22 mmHg
排除标准
- •a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension d. treatment with steroids within the last 3 months from inclusion e. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination k. ocular surface defects l. need for polytherapy in glaucoma treatment
研究组 & 干预措施
BAK-preserved
Xalatan eye drop
干预措施: Xalatan (Drug)
Preservative-free
Monoprost eye drop
干预措施: Monoprost (Drug)
结局指标
主要结局
Goblet cell density
时间窗: 3 months
Change in goblet cell density
次要结局
- Ocular surface disease index evaluation(3 months)
- Intraocular pressure(3 months)
- Cytokines in tear film(3 months)
- Ocular surface(3 months)
- Mucin content in tear film(3 months)
研究者
Anne Hedengran Nagstrup
Department of ophthalmology
Rigshospitalet, Denmark