Trial Outcomes & Findings for Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (NCT NCT03751098)
NCT ID: NCT03751098
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.
COMPLETED
PHASE3
76 participants
35 minutes after initial dose
2022-03-18
Participant Flow
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.
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.
Unit of analysis: eyes
Participant milestones
| Measure |
1-TR/PE, 2-Placebo, 3-Placebo
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.
|
1-Placebo, 2-Placebo, 3-TR/PE
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.
|
|---|---|---|
|
Overall Study
STARTED
|
37 74
|
33 66
|
|
Overall Study
COMPLETED
|
37 74
|
32 64
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 2
|
Reasons for withdrawal
| Measure |
1-TR/PE, 2-Placebo, 3-Placebo
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.
|
1-Placebo, 2-Placebo, 3-TR/PE
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
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=70 Participants
Participants were administered the assigned treatments on 3 separate days (treatment administration sequence was randomized).
|
|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 14.55 • n=99 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 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
|
1 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
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
|
Iris Color Category
Dark
|
50 Participants
n=99 Participants
|
|
Iris Color Category
Light
|
20 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=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser.
|
Placebo - Right Eye
n=69 eyes
Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
Placebo - Left Eye
n=69 eyes
Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|
|
Change in Pupil Diameter From Baseline
Change in 35-minute pupil diameter
|
4.747 millimeters
Standard Deviation 0.7301
|
4.779 millimeters
Standard Deviation 0.8032
|
0.134 millimeters
Standard Deviation 0.4972
|
0.032 millimeters
Standard Deviation 0.4983
|
|
Change in Pupil Diameter From Baseline
Baseline pupil diameter
|
2.597 millimeters
Standard Deviation 0.4784
|
2.524 millimeters
Standard Deviation 0.4802
|
2.632 millimeters
Standard Deviation 0.5202
|
2.559 millimeters
Standard Deviation 0.4666
|
|
Change in Pupil Diameter From Baseline
35-minutes pupil diameter
|
7.344 millimeters
Standard Deviation 0.7981
|
7.304 millimeters
Standard Deviation 0.8264
|
2.766 millimeters
Standard Deviation 0.6598
|
2.590 millimeters
Standard Deviation 0.5892
|
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 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.
Outcome measures
| Measure |
TR/PE - Right Eye
n=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser.
|
Placebo - Right Eye
n=69 eyes
Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
Placebo - Left Eye
n=69 eyes
Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|
|
Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication
|
92.8 percentage of eyes
|
94.2 percentage of eyes
|
0 percentage of eyes
|
0 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 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.
Outcome measures
| Measure |
TR/PE - Right Eye
n=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
TR/PE - Left Eye
n=69 eyes
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser.
|
Placebo - Right Eye
n=69 eyes
Placebo ophthalmic solution administered to the right eye with the Optejet microdose dispenser
|
Placebo - Left Eye
n=69 eyes
Placebo ophthalmic solution administered to the left eye with the Optejet microdose dispenser
|
|---|---|---|---|---|
|
Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication
|
69.6 percentage of eyes
|
68.1 percentage of eyes
|
0 percentage of eyes
|
0 percentage of eyes
|
Adverse Events
Tropicamide/Phenylephrine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tropicamide/Phenylephrine
n=69 participants at risk
Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
|
Placebo
n=70 participants at risk
Placebo ophthalmic solution administered with the Optejet microdose dispenser
|
|---|---|---|
|
Eye disorders
Photophobia
|
1.4%
1/69 • Number of events 1 • Adverse event data was collected over each participant's study participation period, which was a maximum of 14 days.
|
0.00%
0/70 • Adverse event data was collected over each participant's study participation period, which was a maximum of 14 days.
|
|
General disorders
Instillation site pain
|
1.4%
1/69 • Number of events 1 • Adverse event data was collected over each participant's study participation period, which was a maximum of 14 days.
|
0.00%
0/70 • Adverse event data was collected over each participant'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