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A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion

NCT04022382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-09-06

No results posted yet for this study

Summary

A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.

Conditions

  • Dry Eye

Interventions

DEVICE

Restylane Defyne

Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL.

Sponsors & Collaborators

  • John C Meyer, MD

    lead OTHER

Principal Investigators

  • John C Meyer, MD · The Eye Care Institute

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2019-08-26
Completion
2019-08-26
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04022382 on ClinicalTrials.gov