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

April 3, 2013 updated by: Alcon Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • MINI MONOKA
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
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 Names:
  • MINI MONOKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (Day 0) up to Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Retaining the Stent at Month 3
Time Frame: Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Theresa A Landry, Ph.D., Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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