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

NCT03709641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-12-10

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 Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.

Conditions

  • Mild to Moderate Dry Eye Disease

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
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2018-11-28
Completion
2018-11-28
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 NCT03709641 on ClinicalTrials.gov