Dry Eye SyndromeNCT00735865
Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion
A study testing Punctal plugs, punctal cautery, Punctal Plug, Punctal thermocauterization and Silicone plug or thermodynamic hydrophobic acrylic plug in people with Dry Eye Syndrome, run by Lahey Clinic at 2 sites in United States.
Trial summary
To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Punctal plugs, punctal cautery, Punctal Plug, Punctal thermocauterization and Silicone plug or thermodynamic hydrophobic acrylic plug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2003to May 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
- 18 years and older
- Able to sign Informed Consent
- Clinical indication for punctal plug insertion or punctal cautery or symptomatic patients who have previously had punctal occlusion
- Clinical indication for punctal plug removal(Partial extrusion, discomfort) increased signs of ocular irritation with punctate keratopathy, punctal inflammation).
- Able to make follow up visit schedule
Who cannot join
- Subjects without dry eye
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
Lahey Clinic North
Peabody, Massachusetts, 01960
About this study
To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage
Read the detailed description
This study will investigate the impact of punctal occlusion on the ocular microbial flora. Current thought is that punctal occlusion causes retention of inflammatory mediators on the ocular surface which may produce pathology, we hypothesize that blockage of the nasolacrimal drainage system may allow colonization of the ocular surface by potentially pathogenic ubiquitous organisms (which may produce exotoxins and other biologic products) that may be responsible for signs and symptoms seen in some patients. Additionally, the presence of the silicone foreign body(punctal plug) may act as a nidus for bacterial adhesion with biofilm production (which is known to occur with Pseudomonas sp and other organisms). There would thus be a paradigm shift of our current understanding of the pathophysiology of punctal occlusion. Additionally, the choice of antimicrobials for the treatment of infections in patients with punctal occlusion may need to be modified if the microbial flora is found to be different in patients with punctal occlusion.
The ocular flora may be different inpatients with severe dry eye or other chronic pathologic conditions, which are frequent indications for punctal occlusion. However, from our retrospective review, we could not determine if there was a change in the microbial flora following plug placement with colonization with these "unusual organisms" since baseline cultures prior to punctal plug placement were not obtained.
We will try to differentiate any effect on the microbial flora caused by the silicone plug or acrylic plug(as a foreign body) versus the punctal closure by thermocautery. (Punctal thermocauterization is an alternative method of punctal closure which is 1) the preferred choice by some ophthalmologists for all their cases, or 2) when the dry eye is severe and irreversible punctal occlusion is desired or 3) if punctal plugs can not be retained due to the large size of the patients punctal). The thermodynamic hydrophobic acrylic plug(SmartPLUG) approved by the FDA for punctal occlusion with the same indications as the traditional silicone plug.
- Conditions
- Dry Eye Syndrome
- Being tested
- Punctal plugs, punctal cautery, Punctal Plug, Punctal thermocauterization, Silicone plug or thermodynamic hydrophobic acrylic plug, Previous subjects with Punctal occlusion
- Keywords
- Dry Eye Syndrome, Punctal Occlusion, Punctal Plugs, Tear Drainage duct blockage
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punctal plugs, punctal cauteryProcedure or surgery
25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin \& tarsal/inferior fornix conjunctiva obtained \& plated according to protocol
Punctal Plug, Punctal thermocauterizationProcedure or surgery
Up to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization.
This group ONLY, cultures will be obtained of the lid margin \& conjunctiva/inferior fornix of BOTH eyes
Silicone plug or thermodynamic hydrophobic acrylic plugProcedure or surgery
Up to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion.
In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes
Previous subjects with Punctal occlusionOther
Up to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion.
Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Punctal plugs, punctal cautery |
| 2 | Active comparator | Not described Receives: Procedure: Punctal Plug, Punctal thermocauterization |
| 3 | Active comparator | Not described Receives: Procedure: Silicone plug or thermodynamic hydrophobic acrylic plug |
| 4 | Active comparator | Not described Receives: Other: Previous subjects with Punctal occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of punctal occlusion on the ocular microbial flora
Measured: 1 year(3mo, 6mo, 12 mo culture/follow up visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJul 2003
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Sarkis H. Soukiasian, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735865
- Sponsor's protocol ID
- 2003-049
- Status last verified
- May 2009
- First submitted
- 13 Aug 2008
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lid Margin And Conjunctival Microbial Flora Following Punctum Occlusion
- ClinicalTrials.gov ID
- NCT00735865
- Acronym / sponsor ID
- 2003-049
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome, Punctal Occlusion, Punctal Plugs, Tear Drainage duct blockage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Aug 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.
To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage
Detailed description
This study will investigate the impact of punctal occlusion on the ocular microbial flora. Current thought is that punctal occlusion causes retention of inflammatory mediators on the ocular surface which may produce pathology, we hypothesize that blockage of the nasolacrimal drainage system may allow colonization of the ocular surface by potentially pathogenic ubiquitous organisms (which may produce exotoxins and other biologic products) that may be responsible for signs and symptoms seen in some patients. Additionally, the presence of the silicone foreign body(punctal plug) may act as a nidus for bacterial adhesion with biofilm production (which is known to occur with Pseudomonas sp and other organisms). There would thus be a paradigm shift of our current understanding of the pathophysiology of punctal occlusion. Additionally, the choice of antimicrobials for the treatment of infections in patients with punctal occlusion may need to be modified if the microbial flora is found to be different in patients with punctal occlusion.
The ocular flora may be different inpatients with severe dry eye or other chronic pathologic conditions, which are frequent indications for punctal occlusion. However, from our retrospective review, we could not determine if there was a change in the microbial flora following plug placement with colonization with these "unusual organisms" since baseline cultures prior to punctal plug placement were not obtained.
We will try to differentiate any effect on the microbial flora caused by the silicone plug or acrylic plug(as a foreign body) versus the punctal closure by thermocautery. (Punctal thermocauterization is an alternative method of punctal closure which is 1) the preferred choice by some ophthalmologists for all their cases, or 2) when the dry eye is severe and irreversible punctal occlusion is desired or 3) if punctal plugs can not be retained due to the large size of the patients punctal). The thermodynamic hydrophobic acrylic plug(SmartPLUG) approved by the FDA for punctal occlusion with the same indications as the traditional silicone plug.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Punctal plugs, punctal cautery |
| 2 | Active comparator | Procedure: Punctal Plug, Punctal thermocauterization |
| 3 | Active comparator | Procedure: Silicone plug or thermodynamic hydrophobic acrylic plug |
| 4 | Active comparator | Other: Previous subjects with Punctal occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- Able to sign Informed Consent
- Clinical indication for punctal plug insertion or punctal cautery or symptomatic patients who have previously had punctal occlusion
- Clinical indication for punctal plug removal(Partial extrusion, discomfort) increased signs of ocular irritation with punctate keratopathy, punctal inflammation).
- Able to make follow up visit schedule
Key exclusion criteria (1 listed)
- Subjects without dry eye
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 |
|---|---|---|
| Punctal plugs, punctal cautery25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin \& tarsal/inferior fornix conjunctiva obtained \& plated according to protocol | Procedure or surgery | 1 |
| Punctal Plug, Punctal thermocauterizationUp to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization. This group ONLY, cultures will be obtained of the lid margin \& conjunctiva/inferior fornix of BOTH eyes | Procedure or surgery | 2 |
| Silicone plug or thermodynamic hydrophobic acrylic plugUp to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion. In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes | Procedure or surgery | 3 |
| Previous subjects with Punctal occlusionUp to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion. Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol. | Other | 4 |
Primary outcome
Impact of punctal occlusion on the ocular microbial flora
Time frame: 1 year(3mo, 6mo, 12 mo culture/follow up visits)
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 25 May 2009.
Related trials for Dry Eye Syndrome
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
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.
Sarkis H. Soukiasian, M.D. principal investigator
Lahey Clinic, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punctal plugs, punctal cautery, Punctal Plug, Punctal thermocauterization and Silicone plug or thermodynamic hydrophobic acrylic plug in people with Dry Eye Syndrome, run by Lahey Clinic at 2 sites in United States.
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 5 inclusion and 1 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 25 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does the primary outcome measure?
Impact of punctal occlusion on the ocular microbial flora (time frame: 1 year(3mo, 6mo, 12 mo culture/follow up visits)). 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 25 May 2009.