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

NCT00743249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-04-04

Study results available
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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.

Conditions

  • Healthy
  • Dry Eye

Interventions

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

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Theresa A Landry, Ph.D. · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743249 on ClinicalTrials.gov