Low Dose Doxycycline in the Treatment of Corneal Burn

Eye Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01886560
• Other study ID #: SunYat-senU2
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: June 14, 2013
• Last updated: August 7, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: Sun Yat-sen University
• Contact: Dan Liang, MD
• Phone: 0086-20-87331766
• Email: liangd2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Eye Burns

Intervention

Drug:
• Doxycycline
Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
• Placebo
Tablets placebo one PO per day for 12 weeks

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Corneal epithelialization after treatment		24 weeks	No
Secondary	corneal limbal ischemia		12 weeks	No
Secondary	Safety and tolerability as assessed by adverse events, vital signs		24 weeks	Yes
Secondary	corneal neovascularization		12 weeks	No
Secondary	Corneal transparency		12 weeks	No
Secondary	cornea ulcer with perforation		12 weeks	Yes