Safety and Efficacy of a Drug Delivery System in Glaucoma

February 18, 2015 updated by: Vistakon Pharmaceuticals
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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
    • Florida
      • Miami, Florida, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Mount Pleasant, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Maryville, Tennessee, 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
  • 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 Drug Device/ bimatoprost 0.03%
drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Drug: High Dose Drug Device
device inserted for 4 days
Drug: bimatoprost 0.03%
one drop in each eye on one day only
Experimental: Low Dose Drug Device / bimatoprost 0.03%
drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Drug: bimatoprost 0.03%
one drop in each eye on one day only
Drug: Low Dose Drug Device
device inserted for 4 days
Other: Placebo Device / bimatoprost 0.03%
placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).
Drug: bimatoprost 0.03%
one drop in each eye on one day only
Drug: Placebo Device
device inserted for 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Intraocular Pressure at Day 1
Time Frame: Baseline to Day 1
Baseline to Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Intraocular Pressure at Day 2
Time Frame: Baseline to Day 2
Baseline to Day 2
Mean Change in Intraocular Pressure at Day 3
Time Frame: Baseline to Day 3
Baseline to Day 3
Mean Change in Intraocular Pressure at Day 4
Time Frame: Baseline to Day 4
Baseline to Day 4
Mean Change in Intraocular Pressure at Day 5
Time Frame: Day 4 to Day 5
Day 4 to Day 5

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

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (Estimate)

November 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-1649

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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