Evaluation of Pupil Dilation Speed With the MAP Dispenser (SPEED)

August 5, 2021 updated by: Eyenovia Inc.

A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution

After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.

Pupil dilation for each treatment will be compared at each time interval.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Codet Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Photopic screening pupil diameter ≤ 3.5 mm in each eye

Exclusion Criteria:

  1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
  2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
  3. History of closed-angle glaucoma.
  4. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
  5. Ocular surgery or laser treatment of any kind prior to the Screening Visit.
  6. History of iris trauma, surgery, or atrophy.
  7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 Mist
One mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis
Other: 2 Mists
Two mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in pupil diameter from baseline
Time Frame: 35 minutes post drug administration
35 minutes post drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyenovia Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

June 3, 2021

Study Completion (Actual)

June 3, 2021

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYN-MYD-TP-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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