NCT00743249

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Dry Eye

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-08-28
• Last updated: 2013-04-04
• Results posted: 2013-04-04