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OpenTrials
Completed

NCT Number: NCT04907474

Evaluation of Pupil Dilation Speed With the MAP Dispenser

1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CODET Vision Institute

Tijuana, Estado de Baja California, 22010, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Photopic screening pupil diameter ≤ 3.5 mm in each eye

Exclusion criteria

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

Treatment and study plan

tropicamide-phenylephrine fixed combination ophthalmic solution

Drug

Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

Primary outcomes

  1. Mean Change in Pupil Diameter From Baseline

    Time frame: 35 minutes post drug administration

    The primary performance endpoint is Mean Change in pupil diameter at 35 minutes versus per-visit baseline, as measured by digital pupillometry in highly photopic conditions. The highly photopic condition was established using a fully-charged transilluminator (muscle light) at the brightest setting.

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study title

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

Acronym: SPEED

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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