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

Not Applicable

Completed

• Conditions: Healthy; Dry Eye
• Interventions: Device: MINI MONOKA canalicular stent, 10 mm; Device: MINI MONOKA canalicular stent, 20 mm

• Registration Number: NCT00743249
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Study Start: 2008-10
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2013-02-22
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-03
• Last Update Submitted: 2013-04-03
• Results First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canalicular stent, 10 mm	MINI MONOKA 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
Canalicular stent, 20 mm	MINI MONOKA 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

Primary Outcome Measures

Name	Time	Method
Mean Retention Time	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

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