Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00743249

First received: August 26, 2008

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 26, 2008

Last Updated Date

April 3, 2013

Start Date ^ICMJE

October 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean Retention Time [ Time Frame: From baseline (Day 0) up to Month 3 ] [ Designated as safety issue: No ]

At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.

Original Primary Outcome Measures ^ICMJE

Retention time [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00743249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Subjects Retaining the Stent at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.

Original Secondary Outcome Measures ^ICMJE

Retention rate [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers

Official Title ^ICMJE

A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents

Brief 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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

Healthy
Dry Eye

Intervention ^ICMJE

Device: MINI MONOKA canalicular stent, 10 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length

Other Name: MINI MONOKA
Device: MINI MONOKA canalicular stent, 20 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length

Other Name: MINI MONOKA

Study Arm (s)

Experimental: Canalicular stent, 10 mm
MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months

Intervention: Device: MINI MONOKA canalicular stent, 10 mm
Experimental: Canalicular stent, 20 mm
MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months

Intervention: Device: MINI MONOKA canalicular stent, 20 mm

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Sign Informed Consent.
With or without dry eye.
Willing to discontinue contact lenses during the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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.

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00743249

Other Study ID Numbers ^ICMJE

C-07-23

Has Data Monitoring Committee

Responsible Party

Alcon Research

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Theresa A Landry, Ph.D.

Alcon Research

Information Provided By

Alcon Research

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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