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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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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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Detailed Description

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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

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Healthy Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MINI MONOKA canalicular stent, 10 mm

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

MINI MONOKA canalicular stent, 20 mm

Intervention Type DEVICE

40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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MINI MONOKA MINI MONOKA

Eligibility Criteria

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Inclusion Criteria

* Sign Informed Consent.
* With or without dry eye.
* Willing to discontinue contact lenses during the study.

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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes