Eye BurnsPhase 2/3NCT01886560
Low Dose Doxycycline in the Treatment of Corneal Burn
A Phase 2/3 study testing Doxycycline in people with Eye Burns, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eye Burns
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 1. Only one eye function
- 2.The exclusion criteria of the eye
- corneal thinning depth ≥ 1/2CT, corneal perforation or perforation tendency
- B, Dua classification I、II、IV、V、VI
- after injury had received eye operation (such as amniotic membrane transplantation or covering)
- Poor control of intraocular pressure after anti-glaucoma drug treatment (IOP ≥ 25mmHg)
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- past other corneal diseases
- past ocular history of radiation therapy or eye operation history
- eyelid defect, incomplete eyelid closure, entropion, trichiasis
- 3. Any side formulated after secondary infection
- 4. Other rule out criteria
- Tetracycline class history of drug allergy
- poor control of blood pressure (defined as after treatment with antihypertensive drugs, blood pressure is 150/95mmHg or higher)
- 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)
- during pregnancy or lactation women (defined as pregnancy urine pregnancy test results in this test)
- child-bearing age subjects (male and female) is suitable precautions during the entire study
- into the group participated in other clinical subjects before 3 months
- people with TB
- nerve with mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Dan Liang, MD, 0086-20-87331766, liangd2@mail.sysu.edu.cn
About this study
Official title: Prospective, Double-blind, Randomized, Controlled Clinical Trial of Low Dose Doxycycline in the Treatment of Corneal Burn
To evaluate the safety and efficacy of oral low dose doxycycline in the treatment of corneal burn.
Read the 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
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Eye Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Dolotard, Tibirox, Biomycin
Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
PlaceboDrug
Also called dummy
Tablets placebo one PO per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Adding eatable flour into the pills Receives: Drug: Placebo |
| Doxycycline treatment | Experimental | Doxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Corneal epithelialization after treatment
Measured: 24 weeks
Secondary outcomes (5)
corneal limbal ischemia
Measured: 12 weeks
Safety and tolerability as assessed by adverse events, vital signs
Measured: 24 weeks
corneal neovascularization
Measured: 12 weeks
Corneal transparency
Measured: 12 weeks
cornea ulcer with perforation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye BurnsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, MD, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886560
- Sponsor's protocol ID
- SunYat-senU2
- Status last verified
- Jun 2013
- First submitted
- 14 Jun 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind, Randomized, Controlled Clinical Trial of Low Dose Doxycycline in the Treatment of Corneal Burn
- ClinicalTrials.gov ID
- NCT01886560
- Acronym / sponsor ID
- SunYat-senU2
- Conditions
- Eye Burns
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdding eatable flour into the pills |
| Doxycycline treatment | Experimental | Drug: DoxycyclineDoxycycline treatment 50mg bid x 14 days then 50mg qd x 10 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Choose poor eyesight as in the study
Key exclusion criteria (19 listed)
- 1. Only one eye function
- 2.The exclusion criteria of the eye
- corneal thinning depth ≥ 1/2CT, corneal perforation or perforation tendency
- B, Dua classification I、II、IV、V、VI
- after injury had received eye operation (such as amniotic membrane transplantation or covering)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Dolotard, Tibirox, BiomycinTablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks. | Drug | Doxycycline treatment |
| PlaceboAlso: dummyTablets placebo one PO per day for 12 weeks | Drug | Placebo |
Primary outcome
Time for Corneal epithelialization after treatment
Time frame: 24 weeks
5 secondary outcomes
corneal limbal ischemia
Time frame: 12 weeks
Safety and tolerability as assessed by adverse events, vital signs
Time frame: 24 weeks
corneal neovascularization
Time frame: 12 weeks
Corneal transparency
Time frame: 12 weeks
cornea ulcer with perforation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Liang, MD study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Doxycycline in people with Eye Burns, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang, MD (0086-20-87331766, liangd2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for Corneal epithelialization after treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.