Back to resultsA Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension, Primary Open Angle Glaucoma
Status
Completed
Phase
Phase 1
Locations
Latvia
Study Type
Interventional
Intervention
VISION5 Product
Sponsored by
About this trial
This is an interventional prevention trial for Ocular Hypertension
Eligibility 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
Sites / Locations
- Contact ForSight VISION5 for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VISION5 Product
Arm Description
VISION5 Product in both eyes
Outcomes
Primary Outcome Measures
Ocular Tonometry (change from baseline)
Secondary Outcome Measures
Safety as assessed by Slit Lamp Exam
Full Information
NCT ID
NCT01943721
First Posted
September 10, 2013
Last Updated
December 15, 2014
Sponsor
ForSight Vision5, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01943721
Brief Title
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Official Title
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ForSight Vision5, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open Angle Glaucoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VISION5 Product
Arm Type
Experimental
Arm Description
VISION5 Product in both eyes
Intervention Type
Drug
Intervention Name(s)
VISION5 Product
Primary Outcome Measure Information:
Title
Ocular Tonometry (change from baseline)
Time Frame
Week 2, 6, 12 and Months 4,5,6
Secondary Outcome Measure Information:
Title
Safety as assessed by Slit Lamp Exam
Time Frame
Weeks 2,6,12 and Months 4,5,6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Rubin
Organizational Affiliation
ForSight VISION5
Official's Role
Study Director
Facility Information:
Facility Name
Contact ForSight VISION5 for Trial Locations
City
Contact ForSight VISION5 for Trial Locations
Country
Latvia
12. IPD Sharing Statement
Learn more about this trial
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
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