Trial Outcomes & Findings for The Effect of Brimonidine (NCT NCT03959176)
NCT ID: NCT03959176
Last Updated: 2024-02-01
Results Overview
To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
Baseline (Pre drop administration)
Results posted on
2024-02-01
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Group 1
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye in both study arms
Tropicamide: 1 drop administered at two different times points in both eyes in both study arms
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both eyes in both study arms
|
Group 2
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye in both study arms
Tropicamide: 1 drop administered at two different times points in both eyes in both study arms
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both eyes in both study arms
|
|---|---|---|
|
First Eye Exam
STARTED
|
7 7
|
6 6
|
|
First Eye Exam
COMPLETED
|
7 7
|
6 6
|
|
First Eye Exam
NOT COMPLETED
|
0 0
|
0 0
|
|
Opposite Eye Exam
STARTED
|
7 7
|
6 6
|
|
Opposite Eye Exam
COMPLETED
|
7 7
|
6 6
|
|
Opposite Eye Exam
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Brimonidine
Baseline characteristics by cohort
| Measure |
Group 1
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye in both study arms
Tropicamide: 1 drop administered at two different times points in both eyes in both study arms
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both eyes in both study arms
|
Group 2
n=6 Participants
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye in both study arms
Tropicamide: 1 drop administered at two different times points in both eyes in both study arms
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both eyes in both study arms
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION .7 • n=99 Participants
|
23.7 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
23.25 years
STANDARD_DEVIATION .64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre drop administration)To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
15.4 millimeters of mercury (mmHg)
Standard Deviation 2.4
|
16.3 millimeters of mercury (mmHg)
Standard Deviation 2.4
|
16.5 millimeters of mercury (mmHg)
Standard Deviation 1.5
|
16.7 millimeters of mercury (mmHg)
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 15 minutes post drop administrationTo observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
15.3 mmHg
Standard Deviation 2.0
|
13.1 mmHg
Standard Deviation 1.5
|
13.5 mmHg
Standard Deviation 1.7
|
15.0 mmHg
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 30 minutes post drop administrationTo observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Participants
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Participants
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
14.6 mmHg
Standard Deviation 1.7
|
12.3 mmHg
Standard Deviation 1.5
|
14.3 mmHg
Standard Deviation 1.8
|
14.8 mmHg
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: 1 hour post drop administrationTo observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
15.1 mmHg
Standard Deviation 2.0
|
12.4 mmHg
Standard Deviation 1.8
|
13.5 mmHg
Standard Deviation 2.0
|
13.2 mmHg
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 2 hour post drop administrationTo observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
14.3 mmHg
Standard Deviation 1.7
|
11.9 mmHg
Standard Deviation 1.4
|
12.7 mmHg
Standard Deviation 1.0
|
14.2 mmHg
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 4 hour post drop administrationTo observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Intraocular Pressure
|
12.4 mmHg
Standard Deviation 1.7
|
9.3 mmHg
Standard Deviation 1.3
|
11.0 mmHg
Standard Deviation 1.2
|
13.7 mmHg
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline (Pre drop administration)Pupil size measurement
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
3.7 millimeter (mm)
Standard Deviation .4
|
3.7 millimeter (mm)
Standard Deviation .4
|
4.1 millimeter (mm)
Standard Deviation .4
|
4.1 millimeter (mm)
Standard Deviation .4
|
SECONDARY outcome
Timeframe: 15 minutes post drop administrationPupil size measurement.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
7.9 mm
Standard Deviation .4
|
8.6 mm
Standard Deviation .3
|
7.6 mm
Standard Deviation .4
|
7.9 mm
Standard Deviation .3
|
SECONDARY outcome
Timeframe: 30 minutes post drop administrationPupil size measurement
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
8.3 mm
Standard Deviation .4
|
9.6 mm
Standard Deviation .2
|
8.1 mm
Standard Deviation .4
|
8.8 mm
Standard Deviation .4
|
SECONDARY outcome
Timeframe: 1 hour post drop administrationPupil size measurement.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
8.9 mm
Standard Deviation .3
|
8.9 mm
Standard Deviation .3
|
8.3 mm
Standard Deviation .4
|
9.1 mm
Standard Deviation .2
|
SECONDARY outcome
Timeframe: 2 hours post drop administrationPupil size measurement.
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
8.7 mm
Standard Deviation .3
|
8.7 mm
Standard Deviation .3
|
7.8 mm
Standard Deviation .5
|
8.6 mm
Standard Deviation .3
|
SECONDARY outcome
Timeframe: 4 hours post drop administrationPupil size measurement
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Eyes
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=7 Eyes
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
n=6 Eyes
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
n=6 Eyes
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Size
|
7.6 mm
Standard Deviation .4
|
7.6 mm
Standard Deviation .4
|
6.7 mm
Standard Deviation .5
|
7.6 mm
Standard Deviation .7
|
SECONDARY outcome
Timeframe: Baseline (Pre drop administration)Population: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
2 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutes post drop administrationPopulation: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post drop administrationPopulation: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour post drop administrationPopulation: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours post drop administrationPopulation: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hours post drop administrationPopulation: Data only collected for Right Eye in each group.
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Outcome measures
| Measure |
Group 1 Right Eye
n=7 Participants
The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 1 Left Eye
n=6 Participants
The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both left and right eyes
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes
|
Group 2 Right Eye
The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes.
|
Group 2 Left Eye
The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.
Brimonidine: 2 drops administered once in the left eye
Tropicamide: 1 drop administered at two different times points in both the left and right eyes.
Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes.
|
|---|---|---|---|---|
|
Pupil Reaction to Light
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
—
|
—
|
Adverse Events
Group 1 Right Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1 Left Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Right Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Left Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Group 1 Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Group 2 Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Keith Walter, MD
Wake Forest University School of Medicine
Phone: 336-716-2144
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place