NCT01229488

Brief Summary

The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen concentrations to monitor oxygen concentrations on the surface of the eye. This will have obvious applications in eye research and contact lens testing.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

October 26, 2010

Last Update Submit

March 25, 2015

Conditions

Normal

Outcome Measures

Primary Outcomes (1)

  • oxygen tension measurement by new device is comparable with gold standard, but less variable and faster.

    2 weeks

Study Arms (1)

No Arms

NO INTERVENTION

Project was withdrawn before starting

Device: Intervention

Interventions

InterventionDEVICE

Project was withdrawn before starting. There were no interventions

No Arms

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • contact lens wear in last 6 weeks
  • Use of topical drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2010

First Posted

October 27, 2010

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)