Eye Burns
Conditions
Brief summary
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.
Detailed description
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.
Interventions
DRUGDoxycycline
Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
DRUGPlacebo
Tablets placebo one PO per day for 12 weeks
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.age from 18-70 years old, not limited to sex 2\. ocular burn (including chemical injury, thermal burns) 3\. studies of eye with Dua grade (2001) III, within 14 days after burns 4\. about the eye burns 1. become the research with only one eye 2. 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
Exclusion criteria
\- 1. Only one eye function 2.The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for Corneal epithelialization after treatment | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactDan Liang, MD
Backup ContactJingwen Huang
Outcome results
None listed