NCT01886560

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 9, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

June 14, 2013

Last Update Submit

August 7, 2013

Conditions

Eye Burns

Outcome Measures

Primary Outcomes (1)

  • Time for Corneal epithelialization after treatment

    24 weeks

Secondary Outcomes (5)

  • corneal limbal ischemia

    12 weeks

  • Safety and tolerability as assessed by adverse events, vital signs

    24 weeks

  • corneal neovascularization

    12 weeks

  • Corneal transparency

    12 weeks

  • cornea ulcer with perforation

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Adding eatable flour into the pills

Drug: Placebo

Doxycycline treatment

EXPERIMENTAL

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

Drug: Doxycycline

Interventions

DoxycyclineDRUG

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

Also known as: Dolotard, Tibirox, Biomycin
Doxycycline treatment
PlaceboDRUG

Tablets placebo one PO per day for 12 weeks

Also known as: dummy
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18-70 years old, not limited to sex
  • \. ocular burn (including chemical injury, thermal burns)
  • \. studies of eye with Dua grade (2001) III, within 14 days after burns
  • \. 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
  • signed informed consent form

You may not qualify if:

  • \- 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
  • \. Any side formulated after secondary infection
  • \. 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Eye Burns

Interventions

Doxycyclinesulfadiazine, tetroxoprim drug combinationChlortetracycline

Condition Hierarchy (Ancestors)

Eye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesBurnsWounds and Injuries

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dan Liang, MD

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

    STUDY CHAIR

Central Study Contacts

Dan Liang, MD

CONTACT

0086-20-87331766liangd2@mail.sysu.edu.cn

Jingwen Huang

CONTACT

0086-20-87331541shoouzhang35@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 26, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 9, 2013

Record last verified: 2013-06

Locations

CN(1)