HordeolumPhase 3NCT00534391
Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage
A Phase 3 study testing neomycin sulfate, polymyxin B sulfate and gramicidin and Artificial tear in people with Hordeolum, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hordeolum
- What is being tested?
- neomycin sulfate, polymyxin B sulfate and gramicidin and Artificial tear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 5-millimeters hordeolum
- the onset within 7 days
Who cannot join
- previous incision and curettage of the same site within 1 month or more than 3 times
- lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
- The patients with immunodeficiency, history of bleeding tendency
- allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Chulalongkorn University
Bangkok, 10330
Parima Hirunwiwatkul, MD, 662-2564142 ext. 205, parima.H@chula.ac.th
Puangphet Chalermphanich, MD, 662-256-4142 ext. 207, puangphet_c@yahoo.com
About this study
Official title: Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial
To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage
Read the detailed description
Hordeolum is a common eyelid disease. In case of mass, I\&C is required but role of antibiotic after I\&C is not clear. It may not need in post drainage period.
- Conditions
- Hordeolum
- Being tested
- neomycin sulfate, polymyxin B sulfate and gramicidin, Artificial tear
- Keywords
- Antibiotics, hordeolum
- Medical subject headings
- Hordeolum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neomycin sulfate, polymyxin B sulfate and gramicidinDrug
Also called Neosporin, Polyoph
to the effected eye 4 times a day
Artificial tearDrug
Also called Tear natural II, Lacoph
4 times daily
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Artificial tear containing antibiotic solution base Receives: Drug: Artificial tear |
| A | Experimental | combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) Receives: Drug: neomycin sulfate, polymyxin B sulfate and gramicidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
Measured: 1,3,7 days after treatment
Secondary outcomes (1)
Mass size and duration of cure
Measured: 1, 3, 7, 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startSep 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HordeolumStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Parima Hirunwiwatkul, MD, Principal investigator, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534391
- Sponsor's protocol ID
- 59/50
- Status last verified
- Nov 2010
- First submitted
- 21 Sep 2007
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hirunwiwatkul P, Wachirasereechai K. Effectiveness of combined antibiotic ophthalmic solution in the treatment of hordeolum after incision and curettage: a randomized, placebo-controlled trial: a pilot study. J Med Assoc Thai. 2005 May;88(5):647-50.
PubMed 16149682
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00534391
- Acronym / sponsor ID
- 59/50
- Conditions
- Hordeolum
- Keywords
- Antibiotics, hordeolum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 24 Sep 2007 (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 compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage
Detailed description
Hordeolum is a common eyelid disease. In case of mass, I\&C is required but role of antibiotic after I\&C is not clear. It may not need in post drainage period.
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 |
|---|---|---|
| B | Placebo comparator | Drug: Artificial tearArtificial tear containing antibiotic solution base |
| A | Experimental | Drug: neomycin sulfate, polymyxin B sulfate and gramicidincombined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 5-millimeters hordeolum
- the onset within 7 days
Key exclusion criteria (4 listed)
- previous incision and curettage of the same site within 1 month or more than 3 times
- lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
- The patients with immunodeficiency, history of bleeding tendency
- allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine
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 |
|---|---|---|
| neomycin sulfate, polymyxin B sulfate and gramicidinAlso: Neosporin, Polyophto the effected eye 4 times a day | Drug | A |
| Artificial tearAlso: Tear natural II, Lacoph4 times daily | Drug | B |
Primary outcome
Pain scale
Time frame: 1,3,7 days after treatment
1 secondary outcome
Mass size and duration of cure
Time frame: 1, 3, 7, 30 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
- Background: PubMed 16149682Hirunwiwatkul P, Wachirasereechai K. Effectiveness of combined antibiotic ophthalmic solution in the treatment of hordeolum after incision and curettage: a randomized, placebo-controlled trial: a pilot study. J Med Assoc Thai. 2005 May;88(5):647-50.
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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.
Parima Hirunwiwatkul, MD principal investigator
Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neomycin sulfate, polymyxin B sulfate and gramicidin and Artificial tear in people with Hordeolum, run by Chulalongkorn University at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Nov 2010. 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 Thailand. 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 phase mean?
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 Parima Hirunwiwatkul, MD (662-2564142 ext. 205, parima.H@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 1,3,7 days after treatment). 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 NCT00534391, which also lists 1 linked publication.
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 23 Nov 2010.