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Low Dose Doxycycline in the Treatment of Corneal Burn

Primary Purpose

Eye Burns

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Doxycycline

Placebo

About this trial

This is an interventional treatment trial for Eye Burns

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Doxycycline treatment

Arm Description

Adding eatable flour into the pills

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

Outcomes

Primary Outcome Measures

Time for Corneal epithelialization after treatment

Secondary Outcome Measures

corneal limbal ischemia

Safety and tolerability as assessed by adverse events, vital signs

corneal neovascularization

Corneal transparency

cornea ulcer with perforation

Full Information

NCT ID

NCT01886560

First Posted

June 14, 2013

Last Updated

August 7, 2013

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01886560

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eye Burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Adding eatable flour into the pills

Arm Title

Doxycycline treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Other Intervention Name(s)

Dolotard, Tibirox, Biomycin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

dummy

Intervention Description

Tablets placebo one PO per day for 12 weeks

Primary Outcome Measure Information:

Title

Time for Corneal epithelialization after treatment

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

corneal limbal ischemia

Time Frame

12 weeks

Title

Safety and tolerability as assessed by adverse events, vital signs

Time Frame

24 weeks

Title

corneal neovascularization

Time Frame

12 weeks

Title

Corneal transparency

Time Frame

12 weeks

Title

cornea ulcer with perforation

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 become the research with only one eye 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dan Liang, MD

Phone

0086-20-87331766

liangd2@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jingwen Huang

Phone

0086-20-87331541

shoouzhang35@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Liang, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dan Liang, MD

Phone

0086-20-87331766

liangd2@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Low Dose Doxycycline in the Treatment of Corneal Burn

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