A Study of the VISION5 Product in Patients With Glaucoma... | NCT01943721

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

NCT01943721

Sponsor

ForSight Vision5, Inc.

Status

Completed

Last Update Posted

Dec 17, 2014Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Ocular Hypertension
Primary Open Angle Glaucoma

Interventions

VISION5 Product

Countries

Latvia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Sep 10, 2013

First Submission Date that Met QC Criteria

Sep 12, 2013

First Posted Date

Sep 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VISION5 Product	Experimental	VISION5 Product in both eyes	Drug: VISION5 Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VISION5 Product	Drug		VISION5 Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Tonometry (change from baseline)		Week 2, 6, 12 and Months 4,5,6

Secondary Outcomes

Measure	Description	Time Frame
Safety as assessed by Slit Lamp Exam		Weeks 2,6,12 and Months 4,5,6

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Rubin	ForSight VISION5	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact ForSight VISION5 for Trial Locations		Contact ForSight Vision5 For Trial Locations			Latvia

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005128	Eye Diseases
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided