Low Dose Doxycycline in the Treatment of Corneal Burn

NCT ID: NCT01886560

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Eye Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Adding eatable flour into the pills

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets placebo one PO per day for 12 weeks

Doxycycline treatment

Doxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.

Interventions

Doxycycline

Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.

Intervention Type: DRUG

Placebo

Tablets placebo one PO per day for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Dolotard; Tibirox; Biomycin; dummy

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Dan Liang

Zhongshan Ophthalmic Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dan Liang, MD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Dan Liang, MD

Role: CONTACT

Phone: 0086-20-87331766

Email: liangd2@mail.sysu.edu.cn

Jingwen Huang

Role: CONTACT

Phone: 0086-20-87331541

Email: shoouzhang35@sina.com

Facility Contacts

Dan Liang, MD

Role: primary

Other Identifiers

SunYat-senU2

Identifier Type: -

Identifier Source: org_study_id