Prospective, Double-blind, Randomized, Controlled Clinical Trial of Low Dose Doxycycline in the Treatment of Corneal Burn
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time for Corneal epithelialization after treatment
研究概览
简要总结
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.
详细描述
Severe Ocular Burn often leads to the Ocular surface failure, corneal vascularization dissolved hole or corneal opacity.Because the conventional treatment effect is not ideal, blindness rate is extremely high, has been a very challenging catastrophic ophthalmic emergency.Early effective inhibition of inflammation, promote healing of corneal epithelium is the key of reducing corneal perforation, corneal neovascularization, improving corneal transparency.Existing anti-inflammatory treatment including the hormone and immune inhibitors, auto-serum, non-steroidal anti-inflammatory drugs, amniotic membrane transplantation or amniotic membrane patch, etc.Although these measures have some effect, they have their disadvantages.Select both broad-spectrum anti-inflammatory effects and moderate price, good safety anti-inflammatory drugs is particularly important.
Sub-antimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action.This mode of action has lead to the routine use of sub-antimicrobial dose doxycycline for treating inflammatory or autoimmune diseases, such as rosacea, periodontitis and multiple sclerosis.We confirmed on the basis of predecessors' studies that low dose oral doxycycline and topical application of doxycycline can accelerate corneal epithelium healing after ocular surface burn, effectively inhibit inflammation mediated corneal new angiogenesis.Its mechanism of action is about downregulate MMP2 and nitric oxide synthase.
Given the previous research obtained the encouraging result, we plan to carry out a clinical research, to explore oral low-dose doxycycline efficacy and safety of the treatment of corneal burns.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.age from 18-70 years old, not limited to sex
- •ocular burn (including chemical injury, thermal burns)
- •studies of eye with Dua grade (2001) III, within 14 days after burns
- •about the eye burns
- •become the research with only one eye
- •conform to the standards of subjects for the eyes
- •Choose poor eyesight as in the study
- •If the vision is the same on both sides, the choice classification is higher as the research of eye
- •If the binocular vision and graded at the same time, according to a study in can be determined in consultation with the patient's eye
- •5.signed informed consent form
排除标准
- •Only one eye function
- •2.The exclusion criteria of the eye
- •A) corneal thinning depth ≥ 1/2CT, corneal perforation or perforation tendency
- •B, Dua classification I、II、IV、V、VI
- •C) after injury had received eye operation (such as amniotic membrane transplantation or covering)
- •D) Poor control of intraocular pressure after anti-glaucoma drug treatment (IOP ≥ 25mmHg)
- •E) past other corneal diseases
- •F) past ocular history of radiation therapy or eye operation history
- •G) eyelid defect, incomplete eyelid closure, entropion, trichiasis
- •Any side formulated after secondary infection
- •Other rule out criteria
- •A) Tetracycline class history of drug allergy
- •B) poor control of blood pressure (defined as after treatment with antihypertensive drugs, blood pressure is 150/95mmHg or higher)
- •C) serious heart, hepatic, renal insufficiency (or myocardial infarction, arrhythmia, myocardial ischemia and cardiac insufficiency, ALT, AST, upper limit of normal or higher by 2.5 times, creatinine upper limit of normal or higher by 1.5 times)
- •D) during pregnancy or lactation women (defined as pregnancy urine pregnancy test results in this test)
- •E) child-bearing age subjects (male and female) is suitable precautions during the entire study
- •F) into the group participated in other clinical subjects before 3 months
- •G) people with TB
- •H) nerve with mental illness
研究组 & 干预措施
Placebo
Adding eatable flour into the pills
干预措施: Placebo (Drug)
Doxycycline treatment
Doxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks
干预措施: Doxycycline (Drug)
结局指标
主要结局
Time for Corneal epithelialization after treatment
时间窗: 24 weeks
次要结局
- corneal limbal ischemia(12 weeks)
- Safety and tolerability as assessed by adverse events, vital signs(24 weeks)
- corneal neovascularization(12 weeks)
- Corneal transparency(12 weeks)
- cornea ulcer with perforation(12 weeks)
研究者
Dan Liang
Zhongshan Ophthalmic Center
Sun Yat-sen University