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

Mydriasis Clinical Trial

— MIST-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751098
• Other study ID #: EYN-MYD-TP-32
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: January 2022
• Source: Eyenovia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mydriasis

Intervention

Drug:
• Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
• Placebo
Eyewash administered with the Optejet microdose dispenser

Locations

Country	Name	City	State
United States	Keystone Research	Austin	Texas
United States	R&R Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication	The percent of eyes with pupil diameter 6.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 69 participants received each medication. Data is reported separately for the right and left eyes of the 69 participants. A higher percentage indicates a better outcome.	35 minutes after initial dose
Other	Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication	The percent of eyes with pupil diameter 7.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 69 participants received each solution. Data is reported separately for the right and left eyes of the 69 participants. A higher percentage indicates a better outcome.	35 minutes after initial dose
Primary	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