Status:
COMPLETED
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Lead Sponsor:
Eyenovia Inc.
Conditions:
Mydriasis
Eligibility:
All Genders
Phase:
PHASE3
Brief 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....
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 criter...
Eligibility Criteria
Inclusion
- Ability to provide written consent and return for all study visits
- Photopic pupil diameter \<= 3.5 mm in each eye
Exclusion
- 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
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03751631
Start Date
November 15 2018
End Date
January 11 2019
Last Update
March 18 2022
Active Locations (1)
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1
WCCT
Cypress, California, United States, 90630