Safety and Efficacy of a Glaucoma Drug Delivery System

February 18, 2015 updated by: Vistakon Pharmaceuticals
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Artesia, California, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States, USA
    • South Carolina
      • Mount Pleasant, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or woman 21 years of age or greater
  • must have open angle glaucoma or ocular hypertension.
  • Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

  • Previous glaucoma intraocular surgery or refractive surgery.
  • Planned contact lens use during the study.
  • Clinically significant ocular or systemic disease that might interfere with the study.
  • Use of chronic corticosteroids by any route.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Device
device worn continuously for 14 days
Drug: High Dose Device
inserted for 14 days
Experimental: Low Dose Device
device worn continuously for 14 days
Drug: Low Dose Device
inserted for 14 days
Placebo Comparator: Placebo Device
device worn continuously for 14 days
Device: Placebo Device
inserted for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity - Right Eye
Time Frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
at 14 days
Visual Acuity - Left Eye
Time Frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
at 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure (IOP)
Time Frame: from baseline to 14 days
from baseline to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vistakon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-1630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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