The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
试验速览
- 阶段
- 2 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index score
研究概览
简要总结
In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub.
The primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility.
The grader and the patients will blind to the study group.
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, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.
排除标准
- •Patients with Vitamin D deficiency
- •Patients taking Vitamin D systemic Supplementation
- •Patient with prior ocular surgeries within previous 6 months.
- •Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease
研究组 & 干预措施
Prescribe topical placebo eye drop
干预措施: Topical placebo eye drop (Drug)
Prescribe topical Vitamin D eye drop
干预措施: Topical Vitamin D eye drop (Drug)
结局指标
主要结局
Ocular Surface Disease Index score
时间窗: 3 months
The standard questionnaires.
次要结局
- Tear breakup time (TBUT)(3 months)
- schirmer1(3 months)
- Fluorescein staining test(3 months)
研究者
Zahra Rabbani Khah
Head of Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences