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NCT01943721 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01943721
Other study ID # ForSight VISION5 Study 504
Secondary ID
Status Completed
Phase Phase 1
First received September 10, 2013
Last updated December 15, 2014
Start date October 2013
Est. completion date June 2014

Study information
Verified date December 2014
Source ForSight Vision5, Inc.
Contact n/a
Is FDA regulated No
Health authority Latvia: Institutional Review BoardLatvia: State Agency of Medicines
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• VISION5 Product

Locations
Country Name City State
Latvia Contact ForSight VISION5 for Trial Locations Contact ForSight VISION5 for Trial Locations

Sponsors (1)
Lead Sponsor Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

Latvia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Tonometry (change from baseline) Week 2, 6, 12 and Months 4,5,6 No
Secondary Safety as assessed by Slit Lamp Exam Weeks 2,6,12 and Months 4,5,6 Yes
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