Validation of Osmolarity System: Clinical Usability Study

• Sponsor: I-MED Pharma (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03769324
• Collaborator: (none)
• Enrollment: 200
• Anticipated Duration (Months): 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of Osmolarity System: Clinical Usability Study
• Anticipated Study Start Date: Sep 15, 2019
• Anticipated Primary Completion Date: Dec 15, 2019
• Anticipated Study Completion Date: Feb 15, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Osmolarity Level [Baseline]

   Osmolarity Level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Able to provide consent

Exclusion Criteria:

• Ocular pathology (other than Dry Eye)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• I-MED Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: I-MED Pharma
• ClinicalTrials.gov Identifier: NCT03769324
• Other Study ID Numbers: IPCT201810
• First Posted: Dec 7, 2018
• Last Update Posted: Aug 8, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Aug 8, 2019