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

Phase 3

Completed

Interventions: Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Drug: Placebo

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1-TR/PE, 2-Placebo, 3-Placebo	Tropicamide/Phenylephrine ophthalmic solution (TR/PE)	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.
1-TR/PE, 2-Placebo, 3-Placebo	Placebo	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.
1-Placebo, 2-Placebo, 3-TR/PE	Placebo	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.
1-Placebo, 2-Placebo, 3-TR/PE	Tropicamide/Phenylephrine ophthalmic solution (TR/PE)	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.

Primary Outcome Measures

Name	Time	Method
Change in Pupil Diameter From Baseline	35 minutes after initial dose	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.

Secondary Outcome Measures