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Completed

NCT Number: NCT00743249

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

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.

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Key information

Conditions

Healthy Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MINI MONOKA canalicular stent, 10 mm

Device

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

MINI MONOKA canalicular stent, 20 mm

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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