Low Dose Doxycycline in the Treatment of Corneal Burn
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective, Double-blind, Randomized, Controlled Clinical Trial of Low Dose Doxycycline in the Treatment of Corneal Burn|
- Time for Corneal epithelialization after treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- corneal limbal ischemia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- corneal neovascularization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Corneal transparency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- cornea ulcer with perforation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Adding eatable flour into the pills
Tablets placebo one PO per day for 12 weeks
Other Name: dummy
Experimental: Doxycycline treatment
Doxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks
Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886560
|Contact: Dan Liang, MDemail@example.com|
|Contact: Jingwen Huangfirstname.lastname@example.org|
|Zhongshan Ophthalmic Center||Not yet recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Dan Liang, MD 0086-20-87331766 email@example.com|
|Study Chair:||Dan Liang, MD||Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China|