Chalazion Unspecified Eye, Unspecified EyelidNCT01230593
Chalazion Conservative Treatment Trial
A study testing Hot Compress plus Tobramycin Drops and Ointment, Hot compress plus Tobramycin/Dexamethasone Drops and Ointment and Hot Compresses in people with Chalazion Unspecified Eye, Unspecified Eyelid and Chalazion Left Eye, Unspecified Eyelid, run by McMaster University at 3 sites in 2 countries.
Trial summary
An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid
- What is being tested?
- Hot Compress plus Tobramycin Drops and Ointment, Hot compress plus Tobramycin/Dexamethasone Drops and Ointment and Hot Compresses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients age 18 and above
- Patient with a palpable chalazion on any eyelid
- Patients with multiple chalazia but only a single one on each lid
- Normal lid anatomy enabling lid eversion
Who cannot join
- Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy
- Patients allergic to any agents being used in the study (tobramycin, dexamethasone)
- Patients who have had previous eyelid surgery to the same eyelid as the chalazion
- Patients under 18 years of age
- Patients without palpable lid chalazion
- Patients with multiple chalazia on one eyelid
- Patients with concurrent eyelid infection (cellulitis or conjunctivitis)
- Patients unable to give consent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Elmhurst Hospital Center
Elmhurst, New York, 11373
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments
An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.
- Conditions
- Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Both Eyes
- Being tested
- Hot Compress plus Tobramycin Drops and Ointment, Hot compress plus Tobramycin/Dexamethasone Drops and Ointment, Hot Compresses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot Compress plus Tobramycin Drops and OintmentDrug
Also called Aktob, Tobralcon, Tobrasol, Tobramycin
In addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
Hot compress plus Tobramycin/Dexamethasone Drops and OintmentDrug
Also called Tobramycin/dexamethasone
In addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
Hot CompressesOther
Hot compresses 3x/day to eyelids
| Study group | Role | What they receive |
|---|---|---|
| Hot Compress | Active comparator | "Hot Compress" Receives: Other: Hot Compresses |
| Tobrex | Active comparator | "Hot Compress", "Tobrex Drops", "Tobrex Ointment" Receives: Drug: Hot Compress plus Tobramycin Drops and Ointment |
| Tobradex | Active comparator | "Hot Compress", "Tobradex Drops", "Tobradex Ointment" Receives: Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Resolution
Defined as number of patients with chalazion size regression of 100%
Measured: 4-6 weeks
Secondary outcomes (1)
Chalazion Size Difference Post-Treatment
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
Measured: baseline and 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chalazion Unspecified Eye, Unspecified EyelidStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Edward-Elmhurst Health System
- Responsible party
- Principal investigator, Albert Wu, McMaster University
- Investigators
- Albert Y Wu, M.D., Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230593
- Sponsor's protocol ID
- 10-469
- Status last verified
- Jun 2018
- First submitted
- 27 Oct 2010
- Last updated
- 12 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.
PubMed 29338124
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments
- ClinicalTrials.gov ID
- NCT01230593
- Acronym / sponsor ID
- 10-469
- Conditions
- Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Both Eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Edward-Elmhurst Health System
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hot Compress | Active comparator | Other: Hot Compresses"Hot Compress" |
| Tobrex | Active comparator | Drug: Hot Compress plus Tobramycin Drops and Ointment"Hot Compress", "Tobrex Drops", "Tobrex Ointment" |
| Tobradex | Active comparator | Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment"Hot Compress", "Tobradex Drops", "Tobradex Ointment" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 18 and above
- Patient with a palpable chalazion on any eyelid
- Patients with multiple chalazia but only a single one on each lid
- Normal lid anatomy enabling lid eversion
Key exclusion criteria (8 listed)
- Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy
- Patients allergic to any agents being used in the study (tobramycin, dexamethasone)
- Patients who have had previous eyelid surgery to the same eyelid as the chalazion
- Patients under 18 years of age
- Patients without palpable lid chalazion
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 |
|---|---|---|
| Hot Compress plus Tobramycin Drops and OintmentAlso: Aktob, Tobralcon, Tobrasol, TobramycinIn addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed. | Drug | Tobrex |
| Hot compress plus Tobramycin/Dexamethasone Drops and OintmentAlso: Tobramycin/dexamethasoneIn addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed. | Drug | Tobradex |
| Hot CompressesHot compresses 3x/day to eyelids | Other | Hot Compress |
Primary outcome
Number of Participants With Complete Resolution
Time frame: 4-6 weeks
Defined as number of patients with chalazion size regression of 100%
1 secondary outcome
Chalazion Size Difference Post-Treatment
Time frame: baseline and 4-6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29338124Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.
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.
Albert Y Wu, M.D., Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Compress plus Tobramycin Drops and Ointment, Hot compress plus Tobramycin/Dexamethasone Drops and Ointment and Hot Compresses in people with Chalazion Unspecified Eye, Unspecified Eyelid and Chalazion Left Eye, Unspecified Eyelid, run by McMaster University at 3 sites in 2 countries.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Resolution (time frame: 4-6 weeks). 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 NCT01230593, 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 12 Jun 2018.