Trial Outcomes & Findings for Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma (NCT NCT01175902)
NCT ID: NCT01175902
Last Updated: 2015-01-08
Results Overview
IOP (mean IOP) after 4 weeks of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-01-08
Participant Flow
Seoul St. Mary's Hospital From April, 5th, 2011 to October, 16th, 2014
44 enrolled, 44 completed
Participant milestones
| Measure |
Latanoprost
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma
Baseline characteristics by cohort
| Measure |
Latanoprost
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.72 years
STANDARD_DEVIATION 7.42 • n=93 Participants
|
59.68 years
STANDARD_DEVIATION 7.12 • n=4 Participants
|
60.20 years
STANDARD_DEVIATION 7.20 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
22 participants
n=93 Participants
|
22 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Spherical equivalent
|
-0.74 diopters
STANDARD_DEVIATION 1.95 • n=93 Participants
|
-1.04 diopters
STANDARD_DEVIATION 2.71 • n=4 Participants
|
-0.89 diopters
STANDARD_DEVIATION 2.34 • n=27 Participants
|
|
Central corneal thickness
|
542.73 micrometers
STANDARD_DEVIATION 11.43 • n=93 Participants
|
544.23 micrometers
STANDARD_DEVIATION 17.33 • n=4 Participants
|
543.48 micrometers
STANDARD_DEVIATION 14.53 • n=27 Participants
|
|
Mean deviation of visual field
|
-4.00 decibels
STANDARD_DEVIATION 3.79 • n=93 Participants
|
-2.92 decibels
STANDARD_DEVIATION 2.96 • n=4 Participants
|
-3.46 decibels
STANDARD_DEVIATION 3.41 • n=27 Participants
|
PRIMARY outcome
Timeframe: 4 weeksIOP (mean IOP) after 4 weeks of treatment
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Intraocular Pressure (IOP), Period 1
IOP at 8am
|
13.72 mmHg
Standard Deviation 2.93
|
13.50 mmHg
Standard Deviation 3.09
|
|
Intraocular Pressure (IOP), Period 1
IOP at 10am
|
13.27 mmHg
Standard Deviation 2.37
|
13.36 mmHg
Standard Deviation 2.75
|
|
Intraocular Pressure (IOP), Period 1
IOP at 12pm
|
13.54 mmHg
Standard Deviation 2.30
|
12.63 mmHg
Standard Deviation 2.98
|
|
Intraocular Pressure (IOP), Period 1
IOP at 16pm
|
13.77 mmHg
Standard Deviation 2.50
|
13.77 mmHg
Standard Deviation 2.61
|
|
Intraocular Pressure (IOP), Period 1
IOP at 20pm
|
13.36 mmHg
Standard Deviation 1.89
|
13.63 mmHg
Standard Deviation 2.46
|
PRIMARY outcome
Timeframe: 12 weeksIOP (mean IOP) after treaemt from week 8 to week 12
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Intraocular Pressure (IOP), Period 2
IOP at 8am
|
13.13 mmHg
Standard Deviation 3.02
|
12.36 mmHg
Standard Deviation 2.51
|
|
Intraocular Pressure (IOP), Period 2
IOP at 10am
|
12.81 mmHg
Standard Deviation 3.21
|
12.36 mmHg
Standard Deviation 2.55
|
|
Intraocular Pressure (IOP), Period 2
IOP at 12pm
|
12.54 mmHg
Standard Deviation 3.05
|
12.72 mmHg
Standard Deviation 2.45
|
|
Intraocular Pressure (IOP), Period 2
IOP at 16pm
|
12.81 mmHg
Standard Deviation 3.24
|
13.04 mmHg
Standard Deviation 2.41
|
|
Intraocular Pressure (IOP), Period 2
IOP at 20pm
|
13.40 mmHg
Standard Deviation 2.36
|
13.13 mmHg
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 4 weekssystolic and diastolic BP at 4 weeks after use of eyedrops
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Blood Pressure (BP), Period 1
diastolic BP at 12pm
|
74.22 mmHg
Standard Deviation 9.71
|
73.18 mmHg
Standard Deviation 7.53
|
|
Blood Pressure (BP), Period 1
diastolic BP at 16pm
|
75.27 mmHg
Standard Deviation 10.35
|
72.81 mmHg
Standard Deviation 6.94
|
|
Blood Pressure (BP), Period 1
systolic BP at 8am
|
121.82 mmHg
Standard Deviation 16.25
|
122.82 mmHg
Standard Deviation 17.90
|
|
Blood Pressure (BP), Period 1
systolic BP at 10am
|
120.68 mmHg
Standard Deviation 12.76
|
119.14 mmHg
Standard Deviation 18.01
|
|
Blood Pressure (BP), Period 1
systolic BP at 12pm
|
120.45 mmHg
Standard Deviation 13.22
|
120.55 mmHg
Standard Deviation 17.23
|
|
Blood Pressure (BP), Period 1
systolic BP at 16pm
|
122.09 mmHg
Standard Deviation 13.14
|
118.55 mmHg
Standard Deviation 18.74
|
|
Blood Pressure (BP), Period 1
systolic BP at 20pm
|
123.32 mmHg
Standard Deviation 14.09
|
119.45 mmHg
Standard Deviation 18.92
|
|
Blood Pressure (BP), Period 1
diastolic BP at 8am
|
74.77 mmHg
Standard Deviation 11.45
|
77.36 mmHg
Standard Deviation 8.59
|
|
Blood Pressure (BP), Period 1
diastolic BP at 10am
|
74.50 mmHg
Standard Deviation 11.13
|
73.81 mmHg
Standard Deviation 7.32
|
|
Blood Pressure (BP), Period 1
diastolic BP at 20pm
|
75.95 mmHg
Standard Deviation 11.78
|
74.13 mmHg
Standard Deviation 7.52
|
PRIMARY outcome
Timeframe: 12 weekssystolic and diastolic BP measured after treaemt from week 8 to week 12
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Blood Pressure (BP), Period 2
systolic BP at 20pm
|
123.23 mmHg
Standard Deviation 14.88
|
119.82 mmHg
Standard Deviation 13.34
|
|
Blood Pressure (BP), Period 2
diastolic BP at 8am
|
76.45 mmHg
Standard Deviation 7.71
|
73.72 mmHg
Standard Deviation 9.67
|
|
Blood Pressure (BP), Period 2
diastolic BP at 10am
|
74.86 mmHg
Standard Deviation 8.40
|
72.50 mmHg
Standard Deviation 7.70
|
|
Blood Pressure (BP), Period 2
diastolic BP at 12pm
|
75.54 mmHg
Standard Deviation 7.89
|
72.40 mmHg
Standard Deviation 8.39
|
|
Blood Pressure (BP), Period 2
diastolic BP at 16pm
|
73.45 mmHg
Standard Deviation 7.50
|
71.36 mmHg
Standard Deviation 8.78
|
|
Blood Pressure (BP), Period 2
systolic BP at 8am
|
123.14 mmHg
Standard Deviation 12.58
|
118.41 mmHg
Standard Deviation 15.47
|
|
Blood Pressure (BP), Period 2
systolic BP at 10am
|
123.59 mmHg
Standard Deviation 12.06
|
117.95 mmHg
Standard Deviation 12.73
|
|
Blood Pressure (BP), Period 2
systolic BP at 12pm
|
122.41 mmHg
Standard Deviation 11.89
|
119.05 mmHg
Standard Deviation 13.999
|
|
Blood Pressure (BP), Period 2
systolic BP at 16pm
|
124.50 mmHg
Standard Deviation 12.78
|
118.45 mmHg
Standard Deviation 14.90
|
|
Blood Pressure (BP), Period 2
diastolic BP at 20pm
|
73.81 mmHg
Standard Deviation 8.64
|
74.72 mmHg
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: 4 weeksOPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
Ocular Perfusion Pressure (OPP), Period 1
OPP at 8am
|
46.57 mmHg
Standard Deviation 8.34
|
49.12 mmHg
Standard Deviation 6.76
|
|
Ocular Perfusion Pressure (OPP), Period 1
OPP at 10am
|
46.65 mmHg
Standard Deviation 6.81
|
46.95 mmHg
Standard Deviation 6.06
|
|
Ocular Perfusion Pressure (OPP), Period 1
OPP at 12pm
|
46.21 mmHg
Standard Deviation 6.64
|
48.17 mmHg
Standard Deviation 5.51
|
|
Ocular Perfusion Pressure (OPP), Period 1
OPP at 16pm
|
46.81 mmHg
Standard Deviation 7.14
|
45.44 mmHg
Standard Deviation 5.98
|
|
Ocular Perfusion Pressure (OPP), Period 1
OPP at 20pm
|
47.79 mmHg
Standard Deviation 7.34
|
46.73 mmHg
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: 12 weeksOPP was calculated according to the following formula: OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP OPP after treaemt from week 8 to week 12
Outcome measures
| Measure |
Latanoprost, Period 1
n=22 Participants
Patients on Latanoprost eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
Dorzolamide/Timolol, Period 1
n=22 Participants
Patients on Dorzolamide/Timolol eyedrops
dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day
latanoprost: compare with Cosopt one time a day
|
|---|---|---|
|
OPP, Period 2
OPP at 8am
|
48.36 mmHg
Standard Deviation 6.00
|
46.71 mmHg
Standard Deviation 7.34
|
|
OPP, Period 2
OPP at 10am
|
48.04 mmHg
Standard Deviation 5.98
|
46.07 mmHg
Standard Deviation 5.96
|
|
OPP, Period 2
OPP at 12pm
|
48.47 mmHg
Standard Deviation 5.98
|
45.90 mmHg
Standard Deviation 6.00
|
|
OPP, Period 2
OPP at 16pm
|
47.81 mmHg
Standard Deviation 6.21
|
44.99 mmHg
Standard Deviation 5.80
|
|
OPP, Period 2
OPP at 20pm
|
47.10 mmHg
Standard Deviation 6.70
|
46.70 mmHg
Standard Deviation 5.14
|
Adverse Events
Latanoprost
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dorzolamide/Timolol
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