Validation of Osmolarity System: Clinical Usability Study

August 6, 2019 updated by: I-MED Pharma
Confirmatory trial to validate usability of a new portable osmolarity testing device.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Dry Eye Disease

Description

Inclusion Criteria:

  • Able to provide consent

Exclusion Criteria:

  • Ocular pathology (other than Dry Eye)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Eye Group
Normal eye receiving Osmolarity Test
Diagnostic test: Osmolarity Test
Osmolarity Test
DED Group
Dry Eye Disease receiving Osmolarity Test
Diagnostic test: Osmolarity Test
Osmolarity Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osmolarity Level
Time Frame: Baseline
Osmolarity Level
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I-MED Pharma

Investigators

  • Study Chair: Ilan Hofmann, PhD, I-MED Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 15, 2019

Primary Completion (ANTICIPATED)

December 15, 2019

Study Completion (ANTICIPATED)

February 15, 2020

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (ACTUAL)

December 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPCT201810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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