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Eyenovia MiDD Usability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480906
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eyenovia Inc.

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: Latanoprost Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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)
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : March 17, 2018
Actual Study Completion Date : March 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Latanoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: Microdose administration
Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD
 Drug: Latanoprost
Latanoprost ophthalmic solution administered as a microdose spray
Active Comparator: Eyedrop administration
Latanoprost ophthalmic solution administered as an eyedrop
 Drug: Latanoprost
Latanoprost ophthalmic solution administered as an eyedrop


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480906


Locations
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Panama
Clinica de Ojos Orillac-Calvo
Panama City, Panama
Sponsors and Collaborators
Eyenovia Inc.
Investigators
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Principal Investigator: Reuben Orillac, MD Clinica de Ojos Orillac-Calvo
Principal Investigator: Ernesto Calvo, MD Clinica de Ojos Orillac-Calvo
More Information
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Responsible Party: Eyenovia Inc.
ClinicalTrials.gov Identifier: NCT03480906    
Other Study ID Numbers: EYN-POC-PG-21
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions