Trial Outcomes & Findings for Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (NCT NCT03751631)
NCT ID: NCT03751631
Last Updated: 2022-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
35 minutes after initial dose
Results posted on
2022-03-18
Participant Flow
70 patients signed the study informed consent form and were screened for eligibility between October 31, 2018 and November 16, 2018 at a clinical research center located in Cypress, California.
64 of the 70 participants enrolled initiated treatment. Of those who did not initiate treatment, 4 failed to meet all study eligibility criteria, 1 was exited during screening due to behavioral issues, and 1 was exited after screening (before treatment) because the investigator believed the required number of subjects had initiated treatment.
Unit of analysis: eyes
Participant milestones
| Measure |
TR/PE - TR - PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
TR/PE - PE - TR
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
|
TR - TR/PE - PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
TR - PE - TR/PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
PE - TR/PE - TR
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
|
PE - TR - TR/PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10 20
|
11 22
|
11 22
|
11 22
|
10 20
|
11 22
|
|
Overall Study
Received 1st Drug in Sequence
|
10 20
|
11 22
|
11 22
|
11 22
|
10 20
|
11 22
|
|
Overall Study
Received 2nd Drug in Sequence
|
10 20
|
11 22
|
10 20
|
10 20
|
10 20
|
11 22
|
|
Overall Study
Received 3rd Drug in Sequence
|
10 20
|
11 22
|
10 20
|
10 20
|
10 20
|
11 22
|
|
Overall Study
COMPLETED
|
10 20
|
11 22
|
10 20
|
10 20
|
10 20
|
11 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
1 2
|
1 2
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
TR/PE - TR - PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
TR/PE - PE - TR
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
|
TR - TR/PE - PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
TR - PE - TR/PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
PE - TR/PE - TR
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser.
|
PE - TR - TR/PE
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Baseline characteristics by cohort
| Measure |
All Participants
n=64 Participants
Participants were administered each of the 3 assigned drugs on 3 separate days in the clinic (drug administration sequence was equally randomized across 6 possible administration sequences).
|
|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 12.00 • n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
|
Iris color category
Dark
|
54 Participants
n=99 Participants
|
|
Iris color category
Light
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 35 minutes after initial dosePopulation: Per-protocol population (participants who completed all planned assessments without a major protocol deviation)
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.
Outcome measures
| Measure |
TR/PE - Right Eye
n=62 Participants
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=62 Participants
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
TR - Right Eye
n=62 Participants
Tropicamide 1% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR - Left Eye
n=62 Participants
Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
PE - Right Eye
n=62 Participants
Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
PE - Left Eye
n=62 Participants
Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|---|---|
|
Change in Pupil Diameter From Baseline
Baseline pupil diameter
|
2.672 millimeters
Standard Deviation 0.5673
|
2.583 millimeters
Standard Deviation 0.4674
|
2.657 millimeters
Standard Deviation 0.6016
|
2.569 millimeters
Standard Deviation 0.5211
|
2.651 millimeters
Standard Deviation 0.5749
|
2.584 millimeters
Standard Deviation 0.5344
|
|
Change in Pupil Diameter From Baseline
35-minute pupil diameter
|
7.301 millimeters
Standard Deviation 0.8943
|
7.329 millimeters
Standard Deviation 0.9771
|
6.762 millimeters
Standard Deviation 0.8619
|
6.690 millimeters
Standard Deviation 0.8682
|
3.388 millimeters
Standard Deviation 0.8950
|
3.552 millimeters
Standard Deviation 0.9340
|
|
Change in Pupil Diameter From Baseline
Change in 35-minute pupil diameter
|
4.629 millimeters
Standard Deviation 0.8343
|
4.746 millimeters
Standard Deviation 0.8173
|
4.105 millimeters
Standard Deviation 0.7207
|
4.121 millimeters
Standard Deviation 0.6839
|
0.737 millimeters
Standard Deviation 0.7939
|
0.969 millimeters
Standard Deviation 0.8943
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 35 minutes after initial dosePopulation: Per-protocol population (participants who completed all planned assessments without a major protocol deviation)
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 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome.
Outcome measures
| Measure |
TR/PE - Right Eye
n=62 Eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=62 Eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
TR - Right Eye
n=62 Eyes
Tropicamide 1% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR - Left Eye
n=62 Eyes
Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
PE - Right Eye
n=62 Eyes
Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
PE - Left Eye
n=62 Eyes
Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication
|
95.2 percentage of eyes
|
93.5 percentage of eyes
|
79.0 percentage of eyes
|
77.4 percentage of eyes
|
1.6 percentage of eyes
|
1.6 percentage of eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 35 minutes after initial dosePopulation: Per-protocol population (participants who completed all planned assessments without a major protocol deviation)
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 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome.
Outcome measures
| Measure |
TR/PE - Right Eye
n=62 Eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=62 Eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
TR - Right Eye
n=62 Eyes
Tropicamide 1% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR - Left Eye
n=62 Eyes
Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
PE - Right Eye
n=62 Eyes
Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
PE - Left Eye
n=62 Eyes
Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|---|---|
|
Percentage of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication
|
67.7 percentage of eyes
|
67.7 percentage of eyes
|
43.5 percentage of eyes
|
41.9 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
Adverse Events
Tropicamide/Phenylephrine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tropicamide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phenylephrine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tropicamide/Phenylephrine
n=62 participants at risk
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
|
Tropicamide
n=64 participants at risk
Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser
|
Phenylephrine
n=62 participants at risk
Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
4.7%
3/64 • Number of events 3 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
|
Eye disorders
Visual acuity reduced
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
1.6%
1/64 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
|
Investigations
Vital dye staining cornea present
|
0.00%
0/62 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
0.00%
0/64 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
|
Eye disorders
Eye pain
|
0.00%
0/62 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
0.00%
0/64 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
1.6%
1/62 • Number of events 1 • Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place