Corneal UlcerNCT00789646

Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

A study testing Lidocaine/NSS and NSS/Lidocaine in people with Corneal Ulcer, run by Mahidol University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Corneal Ulcer
What is being tested?: Lidocaine/NSS and NSS/Lidocaine
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Jun 2008to Jun 2009
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.
corneal epithelial defect with stromal infiltration
reaction in anterior chamber
positive for bacteria or fungus
The patients have to receive subconjunctival antibiotic injection twice at least.
The patients must be informed consent.

Who cannot join

The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
Unable to cooperate with the treatment.
Pregnant women

About this study

Official title: Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.

Conditions: Corneal Ulcer
Being tested: Lidocaine/NSS, NSS/Lidocaine
Keywords: corneal ulcer, painless, subconjunctival injection, antibiotics, antifungal, lidocaine
Medical subject headings: Corneal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine/NSSProcedure or surgery
First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection
NSS/LidocaineProcedure or surgery
First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection

Study groups in NCT00789646
Study group	Role	What they receive
NSS/Lidocaine	Experimental	First injection: Normal saline Second injection: 2% Lidocaine without adrenaline Receives: Procedure: NSS/Lidocaine
Lidocaine/NSS	Experimental	First injection: 2% Lidocaine without adrenaline Second injection: Normal saline Receives: Procedure: Lidocaine/NSS

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric rating scale
Measured: immediately after injection

Secondary outcomes (1)

Side effects
Measured: 24 hours after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jun 2009

First posted13 Nov 2008 (estimated)
Study startJun 2008
Primary completionDec 2008
Study completionJun 2009

Why it stopped: Very slow in enrolling participants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Corneal UlcerStudies of the same condition, open and under way.
More trials run by Mahidol 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789646
Sponsor's protocol ID: SI 271/2008
Status last verified: Mar 2019
First submitted: 11 Nov 2008
Last updated: 12 Mar 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Corneal Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.
ClinicalTrials.gov ID: NCT00789646
Acronym / sponsor ID: SI 271/2008
Conditions: Corneal Ulcer
Keywords: corneal ulcer, painless, subconjunctival injection, antibiotics, antifungal, lidocaine
Study type: Interventional
Recruitment status: TerminatedReason stopped: Very slow in enrolling participants
Enrolment: 10 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: Jun 2008
Primary completion: Dec 2008 (actual)
Study completion: Jun 2009 (actual)
First posted: 13 Nov 2008 (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.

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NSS/Lidocaine	Experimental	Procedure: NSS/LidocaineFirst injection: Normal saline Second injection: 2% Lidocaine without adrenaline
Lidocaine/NSS	Experimental	Procedure: Lidocaine/NSSFirst injection: 2% Lidocaine without adrenaline Second injection: Normal saline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.
The patients have to receive subconjunctival antibiotic injection twice at least.
The patients must be informed consent.

Key exclusion criteria (4 listed)

The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
Unable to cooperate with the treatment.
Pregnant women

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
Lidocaine/NSSFirst injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection	Procedure or surgery	Lidocaine/NSS
NSS/LidocaineFirst injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection	Procedure or surgery	NSS/Lidocaine

Primary outcome

Numeric rating scale
Time frame: immediately after injection

1 secondary outcome

Side effects
Time frame: 24 hours after injection

Results and safety

The study was stopped early (reason given: Very slow in enrolling participants). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.

Related trials for Corneal Ulcer

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A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
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Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
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RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine/NSS and NSS/Lidocaine in people with Corneal Ulcer, run by Mahidol University.

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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Very slow in enrolling participants). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric rating scale (time frame: immediately after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00789646.

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 12 Mar 2019.