Trial Outcomes & Findings for Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study (NCT NCT03323164)
NCT ID: NCT03323164
Last Updated: 2020-12-31
Results Overview
Percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)
Results posted on
2020-12-31
Participant Flow
Participant milestones
| Measure |
Timolol
Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.
Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation.
|
Brimonidine
Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.
Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Timolol
Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.
Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation.
|
Brimonidine
Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.
Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining optical coherence tomography (OCT) angiography scans after 2 hours of instillation.
|
|---|---|---|
|
Overall Study
Poor quality imaging/scans
|
2
|
2
|
Baseline Characteristics
Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study
Baseline characteristics by cohort
| Measure |
Timolol
n=16 Participants
Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once.
Timolol Maleate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
|
Brimonidine
n=15 Participants
Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.
Brimonidine Tartrate: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Glaucoma type
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography
Overall group
|
-0.51 percent change
Standard Deviation 6.10
|
2.59 percent change
Standard Deviation 6.47
|
—
|
—
|
|
Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography
POAG
|
-0.96 percent change
Standard Deviation 8.069
|
0.96 percent change
Standard Deviation 6.71
|
—
|
—
|
|
Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography
NTG
|
-0.04 percent change
Standard Deviation 6.67
|
4.12 percent change
Standard Deviation 8.11
|
—
|
—
|
|
Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography
OHTN
|
-0.58 percent change
Standard Deviation 4.48
|
2.37 percent change
Standard Deviation 4.77
|
—
|
—
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Percent change in peripapillary Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm with the use of topical brimonidine or timolol eye drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Changes in Flow Index in Treatment Groups Assessed by OCT Angiography
Overall group
|
-5.23 percent change
Standard Deviation 10.77
|
0.33 percent change
Standard Deviation 5.11
|
—
|
—
|
|
Changes in Flow Index in Treatment Groups Assessed by OCT Angiography
POAG
|
-12.55 percent change
Standard Deviation 12.01
|
0.69 percent change
Standard Deviation 7.64
|
—
|
—
|
|
Changes in Flow Index in Treatment Groups Assessed by OCT Angiography
NTG
|
-4.87 percent change
Standard Deviation 6.35
|
2.76 percent change
Standard Deviation 2.55
|
—
|
—
|
|
Changes in Flow Index in Treatment Groups Assessed by OCT Angiography
OHTN
|
1.71 percent change
Standard Deviation 9.68
|
-2.92 percent change
Standard Deviation 3.05
|
—
|
—
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Comparison of the percent change in peripapillary vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography
Overall group
|
1.70 percent change
Standard Deviation 6.68
|
-0.51 percent change
Standard Deviation 6.10
|
-2.05 percent change
Standard Deviation 3.90
|
2.59 percent change
Standard Deviation 6.47
|
|
Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography
POAG
|
2.89 percent change
Standard Deviation 10.73
|
-1.62 percent change
Standard Deviation 9.15
|
-2.8 percent change
Standard Deviation 4.64
|
0.96 percent change
Standard Deviation 6.71
|
|
Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography
NTG
|
2.02 percent change
Standard Deviation 5.59
|
-0.04 percent change
Standard Deviation 6.67
|
-3.42 percent change
Standard Deviation 4.01
|
4.12 percent change
Standard Deviation 8.11
|
|
Comparison of Percent Changes in Peripapillary Vessel Density in Treatment Groups Assessed by OCT Angiography
OHTN
|
0.44 percent change
Standard Deviation 4.89
|
-0.58 percent change
Standard Deviation 4.48
|
0.34 percent change
Standard Deviation 2.21
|
2.37 percent change
Standard Deviation 4.77
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Comparison of the percent change in peripapillary flow index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography
Overall group
|
2.35 percent change
Standard Deviation 11.66
|
-5.23 percent change
Standard Deviation 10.77
|
1.61 percent change
Standard Deviation 11.10
|
0.33 percent change
Standard Deviation 5.11
|
|
Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography
POAG
|
12.81 percent change
Standard Deviation 15.26
|
-14.91 percent change
Standard Deviation 12.45
|
-3.65 percent change
Standard Deviation 5.33
|
0.69 percent change
Standard Deviation 7.64
|
|
Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography
NTG
|
0.22 percent change
Standard Deviation 1.95
|
-4.87 percent change
Standard Deviation 6.35
|
7.57 percent change
Standard Deviation 16.31
|
2.76 percent change
Standard Deviation 2.55
|
|
Comparison of Percent Changes in Peripapillary Flow Index in Treatment Groups Assessed by OCT Angiography
OHTN
|
-3.89 percent change
Standard Deviation 9.97
|
1.71 percent change
Standard Deviation 9.68
|
-0.26 percent change
Standard Deviation 2.95
|
-2.92 percent change
Standard Deviation 3.05
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Comparison of the percent change in optic nerve head vessel density detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in vessel density after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in vessel density after using topical brimonidine or timolol drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography
Overall
|
1.27 Percent change
Standard Deviation 6.95
|
1.08 Percent change
Standard Deviation 6.67
|
0.32 Percent change
Standard Deviation 4.96
|
0.91 Percent change
Standard Deviation 5.45
|
|
Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography
POAG
|
2.22 Percent change
Standard Deviation 7.87
|
-1.00 Percent change
Standard Deviation 6.02
|
-2.68 Percent change
Standard Deviation 4.37
|
2.65 Percent change
Standard Deviation 4.89
|
|
Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography
NTG
|
2.13 Percent change
Standard Deviation 7.03
|
2.44 Percent change
Standard Deviation 8.21
|
1.70 Percent change
Standard Deviation 6.30
|
0.16 Percent change
Standard Deviation 7.40
|
|
Comparison of Percent Changes in Optic Nerve Head Vessel Density in Treatment Groups Assessed by OCT Angiography
OHTN
|
-0.34 Percent change
Standard Deviation 7.50
|
1.65 Percent change
Standard Deviation 7.31
|
1.67 Percent change
Standard Deviation 2.66
|
0.08 Percent change
Standard Deviation 3.66
|
PRIMARY outcome
Timeframe: 5.5 hours (3 separate 30 minute OCT Angiography scans with 2 hour post-intervention in between each scan)Comparison of the percent change in Optic Nerve Head Flow Index detected by OCT (optical coherence tomography) Angiography using spectrum amplitude decorrelation angiography (SSADA) algorithm before and after the use of topical brimonidine or timolol eye drops to lower eye pressure. The Control groups represent the percent changes in flow index after using artificial tears. The medicine groups (Brimonidine/Timolol) represents the percent changes in flow index after using topical brimonidine or timolol drops to lower eye pressure.
Outcome measures
| Measure |
Brimonidine Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Brimonidine eye drops to lower eye pressure before .
|
Timolol Group
n=15 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
Control T
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) before receiving Timolol eye drops to lower eye pressure before .
|
Timolol
n=16 Participants
POAG (primary open angle glaucoma), NTG (normal tension glaucoma) and OHTN (ocular hypertension) had OCTA (optical coherence tomography angiography) after receiving Timolol eye drops to lower eye pressure before .
|
|---|---|---|---|---|
|
Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography
Overall
|
2.69 percent change
Standard Deviation 12.08
|
-5.24 percent change
Standard Deviation 10.05
|
1.96 percent change
Standard Deviation 9.08
|
-0.69 percent change
Standard Deviation 5.37
|
|
Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography
POAG
|
12.40 percent change
Standard Deviation 14.22
|
-13.73 percent change
Standard Deviation 11.02
|
-2.38 percent change
Standard Deviation 3.64
|
-1.65 percent change
Standard Deviation 7.54
|
|
Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography
NTG
|
0.32 percent change
Standard Deviation 3.42
|
-4.17 percent change
Standard Deviation 5.77
|
6.21 percent change
Standard Deviation 13.79
|
2.47 percent change
Standard Deviation 2.65
|
|
Comparison of Percent Changes in Optic Nerve Head Flow Index in Treatment Groups Assessed by OCT Angiography
OHTN
|
-2.68 percent change
Standard Deviation 13.18
|
0.55 percent change
Standard Deviation 10.65
|
1.21 percent change
Standard Deviation 2.61
|
-3.52 percent change
Standard Deviation 4.04
|
Adverse Events
Timolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brimonidine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place