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Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

NCT03065036 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-02-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DRUG

prestudy topical glaucoma medications

Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

Sponsors & Collaborators

  • Ivantis, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Manfred Tetz, MD · Augentagesklinik Spreebogen Berlin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • Austria
  • Germany
  • Mexico

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 NCT03065036 on ClinicalTrials.gov