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

Study Overview
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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.

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.

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

Conditions
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Healthy, Dry Eye

Intervention / Treatment
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* Device: MINI MONOKA canalicular stent, 10 mm
* Device: MINI MONOKA canalicular stent, 20 mm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canalicular stent, 10 mm<br>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<br>* 40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length<br>* Other names: MINI MONOKA;|
| Experimental: Canalicular stent, 20 mm<br>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<br>* 40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length<br>* Other names: MINI MONOKA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Retention Time | 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 | At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Tear duct, Punctal plug