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Validation of Osmolarity System: Clinical Usability Study

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ClinicalTrials.gov Identifier: NCT03769324
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
I-MED Pharma

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 7, 2018
Last Update Posted Date August 8, 2019
Estimated Study Start Date September 15, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
Osmolarity Level [ Time Frame: Baseline ]
Osmolarity Level
Original Primary Outcome Measures
 (submitted: December 6, 2018)
Osmolarity Level [ Time Frame: Single Visit ]
Osmolarity Level
Change History Complete list of historical versions of study NCT03769324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Osmolarity System: Clinical Usability Study
Official Title Validation of Osmolarity System: Clinical Usability Study
Brief Summary Confirmatory trial to validate usability of a new portable osmolarity testing device.
Detailed Description Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Dry Eye Disease
Condition Dry Eye
Intervention Diagnostic Test: Osmolarity Test
Osmolarity Test
Study Groups/Cohorts
  • Normal Eye Group
    Normal eye receiving Osmolarity Test
    Intervention: Diagnostic Test: Osmolarity Test
  • DED Group
    Dry Eye Disease receiving Osmolarity Test
    Intervention: Diagnostic Test: Osmolarity Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 6, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 15, 2020
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Able to provide consent

Exclusion Criteria:

  • Ocular pathology (other than Dry Eye)
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ilan Hofmann, PhD 514-758-9998 ilan@imedpharma.com
Contact: Omid Khodai, OD 949-735-4727 omid@drkhodai.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03769324
Other Study ID Numbers IPCT201810
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party I-MED Pharma
Study Sponsor I-MED Pharma
Collaborators Not Provided
Investigators
Study Chair: Ilan Hofmann, PhD I-MED Pharma, Inc.
PRS Account I-MED Pharma
Verification Date August 2019