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

Study Overview
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Brief Summary
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This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

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 either the study drug or placebo was administered to both eyes. Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes. Participants' treatment assignments for each treatment visit were equally randomized using 1 of 2 sequences - ABB or BAA, where A was the study drug and B was the placebo.

Official Title
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A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

Conditions
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Mydriasis

Intervention / Treatment
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* Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
* Drug: Placebo


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This trial was a double-masked, placebo-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. placebo. All participants in the trial were to receive each treatment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1-TR/PE, 2-Placebo, 3-Placebo<br>Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye. | Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)<br>* Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser<br>* Other names: Mydcombi;Drug: Placebo<br>* Eyewash administered with the Optejet microdose dispenser<br>|
| Other: 1-Placebo, 2-Placebo, 3-TR/PE<br>Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye. | Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)<br>* Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser<br>* Other names: Mydcombi;Drug: Placebo<br>* Eyewash administered with the Optejet microdose dispenser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pupil Diameter From Baseline | Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome. | 35 minutes after initial dose |