NCT02946125

Brief Summary

This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

October 24, 2016

Last Update Submit

July 25, 2022

Conditions

Mydriasis

Outcome Measures

Primary Outcomes (1)

  • Pupil Dilation

    Mean change in pupil diameter from baseline (prior to study drug administration)

    15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug

Secondary Outcomes (3)

  • Blood Pressure

    10, 15, 30, 45 and 60 minutes post administration of study drug

  • Heart Rate

    10, 15, 30, 45 and 60 minutes post administration of study drug

  • PK (Concentration of free phenylephrine in the blood plasma)

    20 minutes post administration of study drug

Study Arms (3)

MDD-administered EYN-1601

EXPERIMENTAL

EYN-1601 Ophthalmic Solution administered using the Eyenovia MDD

Combination Product: MDD-administered EYN-1601

Phenylephrine 2.5% Eyedrop

ACTIVE COMPARATOR

Phenylephrine Hydrochloride Ophthalmic Solution 2.5% administered as an eyedrop

Drug: Phenylephrine 2.5% Eyedrop

Phenylephrine 10% Eyedrop

ACTIVE COMPARATOR

Phenylephrine Hydrochloride Ophthalmic Solution 10% administered as an eyedrop

Drug: Phenylephrine 10% Eyedrop

Interventions

MDD-administered EYN-1601COMBINATION_PRODUCT

Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery

Also known as: MiDD-administered phenylephrine hydrochloride 10%
MDD-administered EYN-1601
Phenylephrine 2.5% EyedropDRUG

Phenylephrine hydrochloride ophthalmic solution 2.5% eyedrop

Phenylephrine 2.5% Eyedrop
Phenylephrine 10% EyedropDRUG

Phenylephrine hydrochloride ophthalmic solution 10% eyedrop

Phenylephrine 10% Eyedrop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1.
  • Provide signed written consent prior to participation in any study-related procedures

You may not qualify if:

  • Pregnancy or lactation.
  • History of diabetes.
  • History of cardiac, renal, or hepatic impairment or disease.
  • Allergy to phenylephrine hydrochloride.
  • Allergy to benzalkonium chloride.
  • History of closed-angle glaucoma.
  • Anatomically narrow anterior chamber angles (or Shaffer gonioscopic grade of ≥ 2 in either eye).
  • Hypertension or treatment for systemic hypertension.
  • Ocular surgery or laser treatment of any kind in the study eye within 3 months.
  • History of benign prostatic hyperplasia.
  • History of chronic or acute uveitis.
  • History of traumatic iritis or hyphema.
  • History of traumatic mydriasis or angle recession.
  • History of anxiety or panic disorders.
  • History of thyrotoxicosis, hypothyroidism, or endocrine disease.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Artesia, California, 90701, United States

Location

MeSH Terms

Conditions

Mydriasis

Interventions

PhenylephrineOphthalmic Solutions

Condition Hierarchy (Ancestors)

Pupil DisordersEye Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)