NCT04817085

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Visant Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	Visant Medical Canalicular Plug	Plug is inserted into the inferior canaliculi and assessed for 6 months
DEVICE	Commercially available canalicular plug	Plug is inserted into the inferior canaliculi and assessed for 6 months

Timeline

• Start date: 2020-10-06
• Primary completion: 2022-02-09
• Completion: 2022-02-09
• First posted: 2021-03-25
• Last updated: 2022-06-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study