Evaluation of Pupil Dilation Speed With the MAP Dispenser

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2021-06-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Mydriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All subjects received both treatments. Subjects were randomized to treatment order

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Only 1 mist or 2 mists of the drug will be administered per treatment visit and will occur in a randomized sequence order using on of the two sequences AB or BA where A is 1 mist of the fixed combination and B is 2 mists of the fixed combination

Study Groups

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Sequence AB

Sequence AB: 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser

Group Type OTHER

tropicamide-phenylephrine fixed combination ophthalmic solution

Intervention Type DRUG

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

Sequence BA

Sequence BA: 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser

Group Type OTHER

tropicamide-phenylephrine fixed combination ophthalmic solution

Intervention Type DRUG

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

Interventions

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tropicamide-phenylephrine fixed combination ophthalmic solution

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes