Eye Burns Clinical Trial
Official title:
Prospective, Double-blind, Randomized, Controlled Clinical Trial of 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00370812 -
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
|
Phase 2/Phase 3 |