NCT01943721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

September 10, 2013

Last Update Submit

December 15, 2014

Conditions

Ocular HypertensionPrimary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Ocular Tonometry (change from baseline)

    Week 2, 6, 12 and Months 4,5,6

Secondary Outcomes (1)

  • Safety as assessed by Slit Lamp Exam

    Weeks 2,6,12 and Months 4,5,6

Study Arms (1)

VISION5 Product

EXPERIMENTAL

VISION5 Product in both eyes

Drug: VISION5 Product

Interventions

VISION5 ProductDRUG
VISION5 Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact ForSight VISION5 for Trial Locations

Contact ForSight Vision5 For Trial Locations, Latvia

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Officials

  • Anne Rubin

    ForSight VISION5

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 17, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

LA(1)