Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-01-11

Brief Summary

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This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

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Detailed Description

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Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.

Conditions

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Mydriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This trial was a double-masked, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

There were no differences in the presentation of drug administered and all study personnel conducting ophthalmic assessments after drug administration were masked to treatment assignment.

Study Groups

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1-TR/PE, 2-TR, 3-PE

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

1-TR/PE, 2-PE, 3-TR

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

1-TR, 2-TR/PE, 3-PE

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

1-TR, 2-PE, 3-TR/PE

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

1-PE, 2-TR/PE, 3-TR

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

1-PE, 2-TR, 3-TR/PE

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Group Type OTHER

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Intervention Type DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)

Intervention Type DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Interventions

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Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Intervention Type DRUG

Tropicamide 1% ophthalmic solution (TR)

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Intervention Type DRUG

Phenylephrine 2.5% ophthalmic solution (PE)

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Intervention Type DRUG

Other Intervention Names

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Mydcombi

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written consent and return for all study visits
* Photopic pupil diameter \<= 3.5 mm in each eye

Exclusion Criteria

* Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
* History of benign prostatic hyperplasia
* Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
* History of closed-angle glaucoma
* Anatomically narrow anterior chamber angles
* Ocular surgery or laser treatment of any kind
* History of chronic or acute uveitis
* History of traumatic iritis or hyphema
* History of traumatic mydriasis or angle recession
* History of heterochromia
* Irregularly-shaped pupil secondary to ocular trauma or congenital defect.
* History of neurogenic pupil disorder
* History of anterior chamber intraocular lens (IOL) or iris-fixated IOL
* History of iris surgery, iris atrophy, or iris-cornea apposition/touch
* Unwilling or unable to discontinue use of contact lenses at treatment visits.
* Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
* Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
* Pregnancy or lactation

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes