NCT03769324

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

December 6, 2018

Last Update Submit

August 6, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Osmolarity Level

    Osmolarity Level

    Baseline

Study Arms (2)

Normal Eye Group

Normal eye receiving Osmolarity Test

Diagnostic Test: Osmolarity Test

DED Group

Dry Eye Disease receiving Osmolarity Test

Diagnostic Test: Osmolarity Test

Interventions

Osmolarity TestDIAGNOSTIC_TEST

Osmolarity Test

DED GroupNormal Eye Group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dry Eye Disease

You may qualify if:

  • Able to provide consent

You may not qualify if:

  • Ocular pathology (other than Dry Eye)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ilan Hofmann, PhD

    I-MED Pharma, Inc.

    STUDY CHAIR

Central Study Contacts

Ilan Hofmann, PhD

CONTACT

514-758-9998ilan@imedpharma.com

Omid Khodai, OD

CONTACT

949-735-4727omid@drkhodai.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 7, 2018

Study Start

September 15, 2019

Primary Completion

December 15, 2019

Study Completion

February 15, 2020

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share