Validation of Osmolarity System: Clinical Usability Study

I-MED Pharma

Status: Unknown

Conditions: Dry Eye

Treatments: Diagnostic Test: Osmolarity Test

Study type: Observational

Funder types: Industry

Identifiers

NCT03769324

IPCT201810

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to provide consent

Exclusion criteria

• Ocular pathology (other than Dry Eye)

Trial design

200 participants in 2 patient groups

Normal Eye Group

Description:

Normal eye receiving Osmolarity Test

Treatment:

Diagnostic Test: Osmolarity Test

DED Group

Description:

Dry Eye Disease receiving Osmolarity Test

Treatment:

Diagnostic Test: Osmolarity Test