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A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension

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: NCT01943721
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
ForSight Vision5, Inc.

Brief Summary:
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Primary Open Angle Glaucoma Drug: VISION5 Product Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: VISION5 Product
VISION5 Product in both eyes
Drug: VISION5 Product



Primary Outcome Measures :
  1. Ocular Tonometry (change from baseline) [ Time Frame: Week 2, 6, 12 and Months 4,5,6 ]

Secondary Outcome Measures :
  1. Safety as assessed by Slit Lamp Exam [ Time Frame: Weeks 2,6,12 and Months 4,5,6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Primary open-angle glaucoma or ocular hypertension in both eyes
  • Best-corrected distance vision of 20/100 or better
  • Stable visual field

Exclusion Criteria:

  • Cup-to-disc ratio greater than 0.8
  • Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
  • Corneal refractive surgery within prior 6 months
  • Past history of any incisional surgery for glaucoma at any time
  • Corneal abnormalities that would interfere with tonometry readings
  • Current participation in an investigational drug or device study or participation in such a study within 30 days of screening

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): NCT01943721


Locations
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Latvia
Contact ForSight VISION5 for Trial Locations
Contact ForSight VISION5 for Trial Locations, Latvia
Sponsors and Collaborators
ForSight Vision5, Inc.
Investigators
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Study Director: Anne Rubin ForSight VISION5

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Responsible Party: ForSight Vision5, Inc.
ClinicalTrials.gov Identifier: NCT01943721     History of Changes
Other Study ID Numbers: ForSight VISION5 Study 504
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases