MIST-2: Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: 1-TR/PE, 2-Placebo, 3-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. |
Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Other Names:
Drug: Placebo
Eyewash administered with the Optejet microdose dispenser
|
Other: 1-Placebo, 2-Placebo, 3-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. |
Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Other Names:
Drug: Placebo
Eyewash administered with the Optejet microdose dispenser
|
Outcome Measures
Primary Outcome Measures
- 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.
Other Outcome Measures
- Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication [35 minutes after initial dose]
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.
- Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication [35 minutes after initial dose]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Keystone Research | Austin | Texas | United States | 78731 |
2 | R&R Research | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Eyenovia Inc.
Investigators
- Study Director: Tsontcho Ianchulev, MD, MPH, Eyenovia Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- EYN-MYD-TP-32
Study Results
Participant Flow
Recruitment Details | 76 patients signed the study informed consent form and were screened for eligibility between November 19, 2018 and December 14, 2018 at clinical research centers located in San Antonio and Austin, Texas. |
---|---|
Pre-assignment Detail | 70 of the 76 participants enrolled initiated study treatment. Of those who did not initiate treatment, 4 failed to meet all study eligibility criteria and 2 were exited after screening (before treatment) because the required number of subjects had initiated treatment. |
Arm/Group Title | 1-TR/PE, 2-Placebo, 3-Placebo | 1-Placebo, 2-Placebo, 3-TR/PE |
---|---|---|
Arm/Group Description | Participants were administered the assigned treatment in each eye on separate days in the following order: 1st Treatment Day: Tropicamide 1%/Phenylephrine 2.5%, 2nd Treatment Day: Placebo, 3rd Treatment Day: Placebo. Each treatment was administered with the Optejet microdose dispenser. | Participants were administered the assigned treatment in each eye on separate days in the following order: 1st Treatment Day: Placebo, 2nd Treatment Day: Placebo, 3rd Treatment Day: Tropicamide 1%/Placebo 2.5%. Each treatment was administered with the Optejet microdose dispenser. |
Period Title: Overall Study | ||
STARTED | 37 | 33 |
COMPLETED | 37 | 32 |
NOT COMPLETED | 0 | 1 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Participants were administered the assigned treatments on 3 separate days (treatment administration sequence was randomized). |
Overall Participants | 70 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
35.4
(14.55)
|
Sex: Female, Male (Count of Participants) | |
Female |
33
47.1%
|
Male |
37
52.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
35
50%
|
Not Hispanic or Latino |
35
50%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
1
1.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
7
10%
|
White |
62
88.6%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
70
100%
|
Iris Color Category (Count of Participants) | |
Dark |
50
71.4%
|
Light |
20
28.6%
|
Outcome Measures
Title | Change in Pupil Diameter From Baseline |
---|---|
Description | 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. |
Time Frame | 35 minutes after initial dose |
Outcome Measure Data
Analysis Population Description |
---|
Per-protocol population (participants who completed all planned assessments without a major protocol deviation) |
Arm/Group Title | TR/PE - Right Eye | TR/PE - Left Eye | Placebo - Right Eye | Placebo - Left Eye |
---|---|---|---|---|
Arm/Group Description | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser. | Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
Measure Participants | 69 | 69 | 69 | 69 |
Measure eyes | 69 | 69 | 69 | 69 |
Change in 35-minute pupil diameter |
4.747
(0.7301)
|
4.779
(0.8032)
|
0.134
(0.4972)
|
0.032
(0.4983)
|
Baseline pupil diameter |
2.597
(0.4784)
|
2.524
(0.4802)
|
2.632
(0.5202)
|
2.559
(0.4666)
|
35-minutes pupil diameter |
7.344
(0.7981)
|
7.304
(0.8264)
|
2.766
(0.6598)
|
2.590
(0.5892)
|
Title | Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication |
---|---|
Description | 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. |
Time Frame | 35 minutes after initial dose |
Outcome Measure Data
Analysis Population Description |
---|
Per-protocol population (participants who completed all planned assessments without a major protocol deviation) |
Arm/Group Title | TR/PE - Right Eye | TR/PE - Left Eye | Placebo - Right Eye | Placebo - Left Eye |
---|---|---|---|---|
Arm/Group Description | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser. | Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
Measure Participants | 69 | 69 | 69 | 69 |
Measure eyes | 69 | 69 | 69 | 69 |
Number [percentage of eyes] |
92.8
|
94.2
|
0
|
0
|
Title | Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication |
---|---|
Description | 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. |
Time Frame | 35 minutes after initial dose |
Outcome Measure Data
Analysis Population Description |
---|
Per-protocol population (participants who completed all planned assessments without a major protocol deviation) |
Arm/Group Title | TR/PE - Right Eye | TR/PE - Left Eye | Placebo - Right Eye | Placebo - Left Eye |
---|---|---|---|---|
Arm/Group Description | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser. | Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser | Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
Measure Participants | 69 | 69 | 69 | 69 |
Measure eyes | 69 | 69 | 69 | 69 |
Number [percentage of eyes] |
69.6
|
68.1
|
0
|
0
|
Adverse Events
Time Frame | Adverse event data was collected over each participant's study participation period, which was a maximum of 14 days. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Tropicamide/Phenylephrine | Placebo | ||
Arm/Group Description | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser | Placebo ophthalmic solution administered with the Optejet microdose dispenser | ||
All Cause Mortality |
||||
Tropicamide/Phenylephrine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/69 (0%) | 0/70 (0%) | ||
Serious Adverse Events |
||||
Tropicamide/Phenylephrine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/69 (0%) | 0/70 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Tropicamide/Phenylephrine | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/69 (2.9%) | 0/70 (0%) | ||
Eye disorders | ||||
Photophobia | 1/69 (1.4%) | 1 | 0/70 (0%) | 0 |
General disorders | ||||
Instillation site pain | 1/69 (1.4%) | 1 | 0/70 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | VP, Development |
---|---|
Organization | Eyenovia, Inc. |
Phone | 714-269-8838 |
gclasby@eyenoviabio.com |
- EYN-MYD-TP-32