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Eyenovia MiDD Usability Study

E

Eyenovia

Status

Completed

Conditions

Intraocular Pressure

Treatments

Drug: Latanoprost

Study type

Interventional

Funder types

Industry

Identifiers

NCT03480906
EYN-POC-PG-21

Details and patient eligibility

About

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)

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups

Microdose administration
Experimental group
Description:
Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD
Treatment:
Drug: Latanoprost
Drug: Latanoprost
Eyedrop administration
Active Comparator group
Description:
Latanoprost ophthalmic solution administered as an eyedrop
Treatment:
Drug: Latanoprost
Drug: Latanoprost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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