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Validation of Osmolarity System: Clinical Usability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769324
Recruitment Status : Unknown
Verified August 2019 by I-MED Pharma.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
I-MED Pharma

Study Description
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Brief Summary:
Confirmatory trial to validate usability of a new portable osmolarity testing device.

Condition or disease Intervention/treatment
Dry Eye Diagnostic Test: Osmolarity Test

Detailed Description:
Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Osmolarity System: Clinical Usability Study
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : February 15, 2020
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Osmolarity Level [ Time Frame: Baseline ]
    Osmolarity Level


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Dry Eye Disease
Criteria

Inclusion Criteria:

  • Able to provide consent

Exclusion Criteria:

  • Ocular pathology (other than Dry Eye)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769324


Contacts
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Contact: Ilan Hofmann, PhD 514-758-9998 ilan@imedpharma.com
Contact: Omid Khodai, OD 949-735-4727 omid@drkhodai.com

Sponsors and Collaborators
I-MED Pharma
Investigators
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Study Chair: Ilan Hofmann, PhD I-MED Pharma, Inc.
More Information
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Responsible Party: I-MED Pharma
ClinicalTrials.gov Identifier: NCT03769324    
Other Study ID Numbers: IPCT201810
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases