HealthyNCT00743249
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
A study testing MINI MONOKA canalicular stent, 10 mm and MINI MONOKA canalicular stent, 20 mm in people with Healthy and Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- What is being tested?
- MINI MONOKA canalicular stent, 10 mm and MINI MONOKA canalicular stent, 20 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Feb 2009
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign Informed Consent.
- With or without dry eye.
- Willing to discontinue contact lenses during the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the past 6 months.
- Ocular hypertension or glaucoma.
- History of punctal plug/canalicular stent insertion.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.
Read the detailed description
This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.
- Being tested
- MINI MONOKA canalicular stent, 10 mm, MINI MONOKA canalicular stent, 20 mm
- Keywords
- Dry eye, Tear duct, Punctal plug
- 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.
MINI MONOKA canalicular stent, 10 mmDevice
Also called MINI MONOKA
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
MINI MONOKA canalicular stent, 20 mmDevice
Also called MINI MONOKA
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length
| Study group | Role | What they receive |
|---|---|---|
| Canalicular stent, 10 mm | Experimental | MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months Receives: Device: MINI MONOKA canalicular stent, 10 mm |
| Canalicular stent, 20 mm | Experimental | MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months Receives: Device: MINI MONOKA canalicular stent, 20 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Retention Time
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Measured: From baseline (Day 0) up to Month 3
Secondary outcomes (1)
Percentage of Subjects Retaining the Stent at Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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 HealthyStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa A Landry, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743249
- Sponsor's protocol ID
- C-07-23
- Status last verified
- Apr 2013
- First submitted
- 26 Aug 2008
- Last updated
- 4 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
- ClinicalTrials.gov ID
- NCT00743249
- Acronym / sponsor ID
- C-07-23
- Keywords
- Dry eye, Tear duct, Punctal plug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Posted 4 Apr 2013
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 was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.
Detailed description
This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canalicular stent, 10 mm | Experimental | Device: MINI MONOKA canalicular stent, 10 mmMINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months |
| Canalicular stent, 20 mm | Experimental | Device: MINI MONOKA canalicular stent, 20 mmMINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign Informed Consent.
- With or without dry eye.
- Willing to discontinue contact lenses during the study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the past 6 months.
- Ocular hypertension or glaucoma.
- History of punctal plug/canalicular stent insertion.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| MINI MONOKA canalicular stent, 10 mmAlso: MINI MONOKA40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length | Device | Canalicular stent, 10 mm |
| MINI MONOKA canalicular stent, 20 mmAlso: MINI MONOKA40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length | Device | Canalicular stent, 20 mm |
Primary outcome
Mean Retention Time
Time frame: From baseline (Day 0) up to Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
1 secondary outcome
Percentage of Subjects Retaining the Stent at Month 3
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Theresa A Landry, Ph.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing MINI MONOKA canalicular stent, 10 mm and MINI MONOKA canalicular stent, 20 mm in people with Healthy and Dry Eye, run by Alcon Research.
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 5 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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 Apr 2013). 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?
Mean Retention Time (time frame: From baseline (Day 0) up to Month 3). 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 4 Apr 2013.