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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Conditions the study is for: Healthy, Dry Eye
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

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.

Conditions: Healthy, Dry Eye
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 groups in NCT00743249
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.

Oct 2008Feb 2009

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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
Conditions: Healthy, Dry Eye
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.

Detailed description

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

Results posted to the registry on 4 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canalicular Stent, 10 mm	30	28
Canalicular Stent, 20 mm	30	24

Primary outcome: Mean Retention Time

Time frame: From baseline (Day 0) up to Month 3. Mean (Standard Deviation). Unit: Days

Measure	Canalicular Stent, 10 mm n = 28	Canalicular Stent, 20 mm n = 29
Value	87.4 (16.8)	61.9 (36.0)

Population analysed: Intent to treat

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (3 months, 26 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canalicular Stent, 10 mm	0 of 30 (0%)	5 of 30 (16.7%)	Not reported
Canalicular Stent, 20 mm	0 of 30 (0%)	10 of 30 (33.3%)	Not reported

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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Trained Athletes, Untrained
Not yet recruitingPhase 1
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Active, not recruitingPhase 2
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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?

On the ClinicalTrials.gov record for NCT00743249.

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.