Low Dose Doxycycline in the Treatment of Corneal Burn

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Dan Liang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01886560
First received: June 14, 2013
Last updated: August 7, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Eye Burns
Drug: Doxycycline
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Time for Corneal epithelialization after treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
Placebo Comparator: Placebo
Adding eatable flour into the pills
Drug: Placebo
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
Drug: Doxycycline
Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
Other Names:
  • Dolotard
  • Tibirox
  • Biomycin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886560

Contacts
Contact: Dan Liang, MD 0086-20-87331766 liangd2@mail.sysu.edu.cn
Contact: Jingwen Huang 0086-20-87331541 shoouzhang35@sina.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Dan Liang, MD    0086-20-87331766    liangd2@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Dan Liang, MD Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
  More Information

No publications provided

Responsible Party: Dan Liang, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01886560     History of Changes
Other Study ID Numbers: SunYat-senU2
Study First Received: June 14, 2013
Last Updated: August 7, 2013
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Additional relevant MeSH terms:
Facial Injuries
Burns
Eye Burns
Wounds and Injuries
Eye Injuries
Craniocerebral Trauma
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 26, 2014