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An Evaluation of the Clinical Utility and Safety of the Visant Medical Canalicular Plug

Dry Eye Clinical Trial

Official title:
Prospective Multicenter, Randomized, Double-Masked, Controlled Trial to Evaluate Clinical Utility and Safety of the Visant Medical Canalicular Device in Subjects Who Are Candidates for Occlusion With Punctal or Canalicular Plugs

Clinical Trial Summary

This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.

Clinical Trial Description

The objective of this study is to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug over 6 months of subject follow-up. Study subjects who are eligible for enrollment and have provided written informed consent will be randomized in a 2:1 ratio (i.e., 2 subjects randomized to the Visant Medical Canalicular Plug for every 1 subject randomized to a commercially available canalicular plug). All study subjects will be treated bilaterally with plugs placed in the inferior canaliculi. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04817085
Study type Interventional
Source Visant Medical, Inc.
Contact
Status Completed
Phase N/A
Start date October 6, 2020
Completion date February 9, 2022
View Details
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