Phase 3
N=70
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Mydriasis
Bottom Line
View on ClinicalTrials.gov: NCT03751098 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Pupil Diameter From Baseline — 4.747; 4.779; 0.134; 0.032 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tropicamide/Phenylephrine ophthalmic solution (TR/PE) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Eyenovia Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pupil Diameter From Baseline |
4.747; 4.779; 0.134; 0.032; 2.597; 2.524 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03751098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.