A Multicenter Randomized Controlled Trial on Prevention and Treatment of Ocular Surface Injury and Meibomian Gland Dysfunction in Patients Using Anti-Glaucoma Eye Drops
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from baseline in Ocular Surface Disease Index (OSDI) score
研究概览
简要总结
A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.
详细描述
- To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
- •A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye:
- •Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort;
- •The instability of tear film (required): tear break up time (TBUT);
- •Lacrimal secretion: Schirmer I test;
- •The ocular surface damage (strengthen diagnosis): fluorescein staining (FL); in the mentioned in ①+②（TBUT≤5s) or ①+②（TBUT≤10s)+③（<10mm）/④（FL+）。
- •The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study.
- •Voluntary participation in this clinical study, and signed informed consent.
排除标准
- •With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome eat;
- •Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis.
- •Using any artificial tears and except any clinical trials of dry eyes within two weeks.
- •With drug therapy, embolization and surgical treatment of dry eyes.
- •With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.
研究组 & 干预措施
A1 Medicine treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
干预措施: 0.3% sodium hyaluronate ophthalmic solution (Drug)
A1 Medicine treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution, 28 days
干预措施: 0.1% sodium bromide solution (Drug)
A2 Combined treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
干预措施: 0.3% sodium hyaluronate ophthalmic solution (Drug)
A2 Combined treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
干预措施: 0.1% sodium bromide solution (Drug)
A2 Combined treatment group
0.3%sodium hyaluronate ophthalmic solution + 0.1 sodium bromide solution，with meibomian gland massage , 28 days
干预措施: Meibomian gland massage (Other)
B1 Control group
Placebo
干预措施: Placebo (Other)
B2 Experiment group
0.3%sodium hyaluronate ophthalmic solution, 12 months
干预措施: 0.3% sodium hyaluronate ophthalmic solution (Drug)
结局指标
主要结局
Change from baseline in Ocular Surface Disease Index (OSDI) score
时间窗: At screening, 1 month and 2 months for treatment.
Primary indicator
次要结局
- Change from baseline in Tear break up time (TBUT)(At screening, 1 month and 2 months for treatment.)
- Change from baseline in corneal staining scores(At screening, 1 month and 2 months for treatment.)
- Change from baseline in schirmer test(At screening, 1 month and 2 months for treatment.)
研究者
Yingli Li
Principal Investigator
Shenzhen Hospital of Southern Medical University