Intraocular PressureNCT03480906
Eyenovia MiDD Usability Study
A study testing Latanoprost in people with Intraocular Pressure, run by Eyenovia Inc. at 1 site in Panama.
Trial summary
This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePanama
- Study dates
- 12 Mar 2018to 17 Mar 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
- Willing to forego use of contact lenses during study period
- Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
- Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test
Who cannot join
- Prior clinically significant ocular history or abnormal eye exam
- Use of ocular medication within 30 days of screening
- Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
- History of drug or alcohol abuse within 1 year of screening
- Lid squeezer
- Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD
- Participation in any interventional study of an investigational drug or device within 30 days of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)
- Conditions
- Intraocular Pressure
- Being tested
- Latanoprost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Latanoprost ophthalmic solution administered as a microdose spray
LatanoprostDrug
Latanoprost ophthalmic solution administered as an eyedrop
| Study group | Role | What they receive |
|---|---|---|
| Microdose administration | Experimental | Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD Receives: Drug: Latanoprost |
| Eyedrop administration | Active comparator | Latanoprost ophthalmic solution administered as an eyedrop Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful microtherapeutic administration to the ocular surface
Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer
Measured: Treatment Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start12 Mar 2018
- Primary completion17 Mar 2018
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenovia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reuben Orillac, MD, Principal investigator, Clinica de Ojos Orillac-CalvoErnesto Calvo, MD, Principal investigator, Clinica de Ojos Orillac-Calvo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480906
- Sponsor's protocol ID
- EYN-POC-PG-21
- Status last verified
- Jul 2018
- First submitted
- 13 Mar 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
- ClinicalTrials.gov ID
- NCT03480906
- Acronym / sponsor ID
- EYN-POC-PG-21
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eyenovia Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 17 Mar 2018 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 29 Mar 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.
This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microdose administration | Experimental | Drug: LatanoprostLatanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD |
| Eyedrop administration | Active comparator | Drug: LatanoprostLatanoprost ophthalmic solution administered as an eyedrop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
- Willing to forego use of contact lenses during study period
- Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
- Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test
Key exclusion criteria (7 listed)
- Prior clinically significant ocular history or abnormal eye exam
- Use of ocular medication within 30 days of screening
- Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
- History of drug or alcohol abuse within 1 year of screening
- Lid squeezer
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 |
|---|---|---|
| LatanoprostLatanoprost ophthalmic solution administered as a microdose spray | Drug | Microdose administration |
| LatanoprostLatanoprost ophthalmic solution administered as an eyedrop | Drug | Eyedrop administration |
Primary outcome
Successful microtherapeutic administration to the ocular surface
Time frame: Treatment Day 3
Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Reuben Orillac, MD principal investigator
Clinica de Ojos Orillac-Calvo
Ernesto Calvo, MD principal investigator
Clinica de Ojos Orillac-Calvo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost in people with Intraocular Pressure, run by Eyenovia Inc. at 1 site in Panama.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful microtherapeutic administration to the ocular surface (time frame: Treatment Day 3). 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 26 Jul 2018.