Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated (NCT NCT01243567)
NCT ID: NCT01243567
Last Updated: 2019-04-18
Results Overview
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2019-04-18
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
38
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 13.72 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients.
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Outcome measures
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Change From Baseline in Average Intraocular Pressure (IOP)
Baseline
|
28.4 Millimeters of Mercury (mmHg)
Standard Deviation 3.35
|
28.5 Millimeters of Mercury (mmHg)
Standard Deviation 2.57
|
|
Change From Baseline in Average Intraocular Pressure (IOP)
Change from Baseline at Month 3
|
-13.5 Millimeters of Mercury (mmHg)
Standard Deviation 4.48
|
-11.4 Millimeters of Mercury (mmHg)
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients.
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Outcome measures
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Change From Baseline IOP
Change from Baseline at Month 3-12:00
|
-13.6 Millimeters of Mercury (mmHg)
Standard Deviation 5.50
|
-11.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.14
|
|
Change From Baseline IOP
Change from Baseline at Month 3-16:00
|
-12.4 Millimeters of Mercury (mmHg)
Standard Deviation 5.16
|
-10.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.24
|
|
Change From Baseline IOP
Baseline-08:00
|
29.7 Millimeters of Mercury (mmHg)
Standard Deviation 2.97
|
29.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.93
|
|
Change From Baseline IOP
Baseline-12:00
|
28.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.46
|
29.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.60
|
|
Change From Baseline IOP
Baseline-16:00
|
26.8 Millimeters of Mercury (mmHg)
Standard Deviation 4.01
|
26.8 Millimeters of Mercury (mmHg)
Standard Deviation 3.73
|
|
Change From Baseline IOP
Change from Baseline at Month 3-08:00
|
-14.6 Millimeters of Mercury (mmHg)
Standard Deviation 4.04
|
-12.3 Millimeters of Mercury (mmHg)
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients.
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Outcome measures
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Decrease of at Least 20%
|
97.7 Percentage of Patients
|
100.0 Percentage of Patients
|
|
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Decrease of at Least 30%
|
90.7 Percentage of Patients
|
86.8 Percentage of Patients
|
|
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Decrease of at Least 40%
|
74.4 Percentage of Patients
|
47.4 Percentage of Patients
|
|
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Decrease of at Least 50%
|
46.5 Percentage of Patients
|
15.8 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients.
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Outcome measures
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Baseline
|
30.4 Millimeters of Mercury (mmHg)
Standard Deviation 3.19
|
30.3 Millimeters of Mercury (mmHg)
Standard Deviation 2.54
|
|
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Absolute Difference at Month 3
|
-15.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.44
|
-12.9 Millimeters of Mercury (mmHg)
Standard Deviation 3.82
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Intent to Treat: all randomized patients.
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Outcome measures
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 Participants
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 Participants
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Baseline
|
26.2 Millimeters of Mercury (mmHg)
Standard Deviation 4.04
|
26.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.44
|
|
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Absolute Difference at Month 3
|
-11.8 Millimeters of Mercury (mmHg)
Standard Deviation 5.23
|
-9.9 Millimeters of Mercury (mmHg)
Standard Deviation 3.71
|
Adverse Events
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Latanoprost 0.005% Ophthalmic Solution
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 participants at risk
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 participants at risk
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
2.3%
1/43
|
0.00%
0/38
|
Other adverse events
| Measure |
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution
n=43 participants at risk
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
Latanoprost 0.005% Ophthalmic Solution
n=38 participants at risk
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
|
|---|---|---|
|
Eye disorders
Ocular Hyperaemia
|
16.3%
7/43
|
10.5%
4/38
|
|
Eye disorders
Blepharitis
|
2.3%
1/43
|
5.3%
2/38
|
|
Eye disorders
Conjunctival Hyperaemia
|
2.3%
1/43
|
5.3%
2/38
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/43
|
5.3%
2/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER