Dry EyeNCT01947517
The Retention Rate Between Brand A and Brand B Punctal Plugs
An observational study of Dry Eye, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye
- What is being tested?
- Parasol Punctal Occluder and Superflex Punctal Occluder
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Aug 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University
Who may be able to join
- moderate dry eye, severe dry eye
Who cannot join
- silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Ophthalmology, Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
Official title: The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).
Read the detailed description
Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.
- Conditions
- Dry Eye
- Being tested
- Parasol Punctal Occluder, Superflex Punctal Occluder
- 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.
Parasol Punctal OccluderDevice
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Superflex Punctal OccluderDevice
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
| Study group | Role | What they receive |
|---|---|---|
| Parasol Punctal Occluder Group | Randomized to receive Brand A punctal plugs Receives: Device: Parasol Punctal Occluder | |
| Superflex Punctal Occluder Group | Randomized to receive Group B punctal plugs Receives: Device: Superflex Punctal Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Retention
Measured: 6 months
Secondary outcomes (4)
Canadian Dry Eye Assessment Score
Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.
Measured: 6 months
National Eye Institute Corneal Fluorescein Staining Pattern
The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.
Measured: 6 months
National Eye Institute Grading for Conjunctival Staining
The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.
Measured: 6 months
Tear Meniscus Height
Meniscus height measured in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionAug 2014
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.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stephanie Baxter, Queen's University
- Investigators
- Ashley R Brissette, BSc, MD, Study director, Queens UniversityStephanie Baxter, MD, FRCSC, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947517
- Sponsor's protocol ID
- Punctal plugs
- Status last verified
- Mar 2017
- First submitted
- 17 Sep 2013
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
- ClinicalTrials.gov ID
- NCT01947517
- Acronym / sponsor ID
- Punctal plugs
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Posted 16 Jun 2017
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 determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).
Detailed description
Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasol Punctal Occluder Group | – | Device: Parasol Punctal OccluderRandomized to receive Brand A punctal plugs |
| Superflex Punctal Occluder Group | – | Device: Superflex Punctal OccluderRandomized to receive Group B punctal plugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University
Key inclusion criteria (1 listed)
- moderate dry eye, severe dry eye
Key exclusion criteria (1 listed)
- silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
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 |
|---|---|---|
| Parasol Punctal OccluderPatients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes. | Device | Parasol Punctal Occluder Group |
| Superflex Punctal OccluderPatients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes. | Device | Superflex Punctal Occluder Group |
Primary outcome
Length of Retention
Time frame: 6 months
4 secondary outcomes
Canadian Dry Eye Assessment Score
Time frame: 6 months
National Eye Institute Corneal Fluorescein Staining Pattern
Time frame: 6 months
National Eye Institute Grading for Conjunctival Staining
Time frame: 6 months
Tear Meniscus Height
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ashley R Brissette, BSc, MD study director
Queens University
Stephanie Baxter, MD, FRCSC principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Queen's University at 1 site in Canada.
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 1 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 16 Jun 2017. 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 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 16 Jun 2017). 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?
Length of Retention (time frame: 6 months). 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 16 Jun 2017.