Validation of Osmolarity System: Clinical Usability Study

NCT ID: NCT03769324

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-15

Study Completion Date

2020-02-15

Brief Summary

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

Detailed Description

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

Conditions

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Dry Eye

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Eye Group

Normal eye receiving Osmolarity Test

Osmolarity Test

Intervention Type DIAGNOSTIC_TEST

Osmolarity Test

DED Group

Dry Eye Disease receiving Osmolarity Test

Osmolarity Test

Intervention Type DIAGNOSTIC_TEST

Osmolarity Test

Interventions

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Osmolarity Test

Osmolarity Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Able to provide consent

Exclusion Criteria

* Ocular pathology (other than Dry Eye)
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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I-MED Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilan Hofmann, PhD

Role: STUDY_CHAIR

I-MED Pharma, Inc.

Central Contacts

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Ilan Hofmann, PhD

Role: CONTACT

514-758-9998

Omid Khodai, OD

Role: CONTACT

949-735-4727

Other Identifiers

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IPCT201810

Identifier Type: -

Identifier Source: org_study_id

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