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NCT03769324 Clinical Trial

Validation of Osmolarity System: Clinical Usability Study

Dry Eye Clinical Trial

Official title:
Validation of Osmolarity System: Clinical Usability Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03769324
Other study ID # IPCT201810
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 15, 2019
Est. completion date February 15, 2020

Study information
Verified date August 2019
Source I-MED Pharma
Contact Ilan Hofmann, PhD
Phone 514-758-9998
Email ilan@imedpharma.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Confirmatory trial to validate usability of a new portable osmolarity testing device.

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date February 15, 2020
Est. primary completion date December 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria:

- Able to provide consent

Exclusion Criteria:

- Ocular pathology (other than Dry Eye)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Osmolarity Test
Osmolarity Test

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
I-MED Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Osmolarity Level Osmolarity Level Baseline
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