Clinical Trial: Low Dose Doxycycline in the Treatment of Corneal Burn

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective, Double-blind, Randomized, Controlled Clinical Trial of Low Dose Doxycycline in the Treatment of Corneal Burn

Brief Summary: To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.

Detailed Summary:

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.


Sponsor: Sun Yat-sen University

Current Primary Outcome: Time for Corneal epithelialization after treatment [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • corneal limbal ischemia [ Time Frame: 12 weeks ]
  • Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 24 weeks ]
  • corneal neovascularization [ Time Frame: 12 weeks ]
  • Corneal transparency [ Time Frame: 12 weeks ]
  • cornea ulcer with perforation [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: June 14, 2013
Date Started: September 2013
Date Completion: September 2014
Last Updated: August 7, 2013
Last Verified: June 2013