Dry EyeNCT03769324
Validation of Osmolarity System: Clinical Usability Study
An observational study of Dry Eye, run by I-MED Pharma.
Trial summary
Confirmatory trial to validate usability of a new portable osmolarity testing device. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Osmolarity Test
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 15 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dry Eye Disease
Who may be able to join
- Able to provide consent
Who cannot join
- Ocular pathology (other than Dry Eye)
Trial locations and contacts
No sites are listed yet.
About this study
Confirmatory trial to validate usability of a new portable osmolarity testing device.
Read the detailed description
Confirmatory trial at 3 sites in Canada to validate usability of an ocular osmolarity testing device.
- Conditions
- Dry Eye
- Being tested
- Osmolarity Test
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmolarity TestDiagnostic test
Osmolarity Test
| Study group | Role | What they receive |
|---|---|---|
| Normal Eye Group | Normal eye receiving Osmolarity Test Receives: Diagnostic Test: Osmolarity Test | |
| DED Group | Dry Eye Disease receiving Osmolarity Test Receives: Diagnostic Test: Osmolarity Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osmolarity Level
Osmolarity Level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start15 Sep 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-MED Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilan Hofmann, PhD, Study chair, I-MED Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769324
- Sponsor's protocol ID
- IPCT201810
- Status last verified
- Aug 2019
- First submitted
- 6 Dec 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Osmolarity System: Clinical Usability Study
- ClinicalTrials.gov ID
- NCT03769324
- Acronym / sponsor ID
- IPCT201810
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I-MED PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Eye Group | – | Diagnostic Test: Osmolarity TestNormal eye receiving Osmolarity Test |
| DED Group | – | Diagnostic Test: Osmolarity TestDry Eye Disease receiving Osmolarity Test |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dry Eye Disease
Key inclusion criteria (1 listed)
- Able to provide consent
Key exclusion criteria (1 listed)
- Ocular pathology (other than Dry Eye)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osmolarity TestOsmolarity Test | Diagnostic test | DED Group, Normal Eye Group |
Primary outcome
Osmolarity Level
Time frame: Baseline
Osmolarity Level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Dry Eye Disease
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilan Hofmann, PhD study chair
I-MED Pharma, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by I-MED Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Hofmann, PhD (514-758-9998, ilan@imedpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osmolarity Level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.