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Safety and Efficacy of a Glaucoma Drug Delivery System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00824720
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : May 14, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: High Dose Device Drug: Low Dose Device Device: Placebo Device Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: from baseline to 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824720


Locations
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United States, California
Artesia, California, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States, USA
United States, South Carolina
Mount Pleasant, South Carolina, United States
Sponsors and Collaborators
Vistakon Pharmaceuticals
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00824720    
Other Study ID Numbers: CR-1630
First Posted: January 19, 2009    Key Record Dates
Results First Posted: May 14, 2010
Last Update Posted: March 6, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases