Phase 3
N=64
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Mydriasis
Bottom Line
View on ClinicalTrials.gov: NCT03751631 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Pupil Diameter From Baseline — 2.672; 2.583; 2.657; 2.569 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) (Drug); Tropicamide 1% ophthalmic solution (TR) (Drug); Phenylephrine 2.5% ophthalmic solution (PE) (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 |
2.672; 2.583; 2.657; 2.569; 2.651; 2.584 | — |
Summary
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.
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 (NCT03751631). 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.