Dry EyePLPONCT00802399
Partial Lacrimal Punctual Occlusion
A study testing Partial Lacrimal Punctual Occlusion in people with Dry Eye, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Partial Lacrimal Punctual Occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Nov 2008
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sin and symptom of dry eye
- Use more than 4 times a day topic lubricant for the eye
Who cannot join
- Ocular diseases other than dry eye
- Use of systemic drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403010
About this study
Official title: Partial Lacrimal Punctual Occlusion in the Management of Dry Eye
The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.
- Conditions
- Dry Eye
- Being tested
- Partial Lacrimal Punctual Occlusion
- Keywords
- Cornea, Dry eye, lacrimal punctual occlusion, lacrimal film, ocular surface
- Medical subject headings
- Dry Eye Syndromes, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Lacrimal Punctual OcclusionProcedure or surgery
Cauterization of the edge of all lacrimal punctum was carried out in all patients
| Study group | Role | What they receive |
|---|---|---|
| Partial Lacrimal Punctual Occlusion | Other | Cauterization of the edge of all lacrimal punctum was carried out in all patients Receives: Procedure: Partial Lacrimal Punctual Occlusion |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo Holzchuh, MD, Principal investigator, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802399
- Sponsor's protocol ID
- 0300/08
- Acronym
- PLPO
- Status last verified
- Aug 2008
- First submitted
- 3 Dec 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Lacrimal Punctual Occlusion in the Management of Dry Eye
- ClinicalTrials.gov ID
- NCT00802399
- Acronym / sponsor ID
- PLPO / 0300/08
- Conditions
- Dry Eye
- Keywords
- Cornea, Dry eye, lacrimal punctual occlusion, lacrimal film, ocular surface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Dec 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 purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Lacrimal Punctual Occlusion | Other | Procedure: Partial Lacrimal Punctual OcclusionCauterization of the edge of all lacrimal punctum was carried out in all patients |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sin and symptom of dry eye
- Use more than 4 times a day topic lubricant for the eye
Key exclusion criteria (2 listed)
- Ocular diseases other than dry eye
- Use of systemic drugs
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 |
|---|---|---|
| Partial Lacrimal Punctual OcclusionCauterization of the edge of all lacrimal punctum was carried out in all patients | Procedure or surgery | Partial Lacrimal Punctual Occlusion |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
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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.
Ricardo Holzchuh, MD principal investigator
Instituto do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Lacrimal Punctual Occlusion in people with Dry Eye, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 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 22 Jan 2009. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Jan 2009.