Low Dose Doxycycline in the Treatment of Corneal Burn

• ClinicalTrials.gov Identifier: NCT01886560
• Recruitment Status: Unknown
• First Posted: June 26, 2013
• Last Update Posted: August 9, 2013
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Dan Liang, Sun Yat-sen University

Tracking Information

• First Submitted Date: June 14, 2013
• First Posted Date: June 26, 2013
• Last Update Posted Date: August 9, 2013
• Study Start Date: September 2013
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2013): Time for Corneal epithelialization after treatment [ Time Frame: 24 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 23, 2013)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Dose Doxycycline in the Treatment of Corneal Burn
• 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 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.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Eye Burns

Intervention

• Drug: Doxycycline
  Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
  Other Names:

  • Dolotard
  • Tibirox
  • Biomycin
• Drug: Placebo
  Tablets placebo one PO per day for 12 weeks
  Other Name: dummy

Study Arms

• Placebo Comparator: Placebo
  Adding eatable flour into the pills
  Intervention: Drug: Placebo
• Experimental: Doxycycline treatment
  Doxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks
  Intervention: Drug: Doxycycline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 23, 2013): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 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

3. Any side formulated after secondary infection

4. 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01886560
• Other Study ID Numbers: SunYat-senU2
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dan Liang, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dan Liang, MD; Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China

• PRS Account: Sun Yat-sen University
• Verification Date: June 2013