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

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ClinicalTrials.gov Identifier: NCT00743249
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Healthy Dry Eye Device: MINI MONOKA canalicular stent, 10 mm Device: MINI MONOKA canalicular stent, 20 mm Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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 Name: 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 Name: MINI MONOKA



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743249


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa A Landry, Ph.D. Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00743249     History of Changes
Other Study ID Numbers: C-07-23
First Posted: August 28, 2008    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Alcon Research:
Dry eye
Tear duct
Punctal plug