Trial Outcomes & Findings for Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01241240)
NCT ID: NCT01241240
Last Updated: 2014-09-10
Results Overview
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2014-09-10
Participant Flow
Participant milestones
| Measure |
Triple Combination Therapy
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
98
|
|
Overall Study
COMPLETED
|
86
|
89
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Triple Combination Therapy
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Personal Reasons
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Triple Combination Therapy
n=94 Participants
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=98 Participants
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤65 years
|
67 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Age, Customized
>65 years
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Triple Combination Therapy
n=93 Participants
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=97 Participants
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
Baseline (n=93,95)
|
24.62 mmHg
Standard Deviation 2.475
|
25.12 mmHg
Standard Deviation 2.178
|
|
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
Change from Baseline at Week 12 (n=93,94)
|
-10.03 mmHg
Standard Deviation 2.661
|
-9.18 mmHg
Standard Deviation 2.566
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4 and 8Population: Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Triple Combination Therapy
n=93 Participants
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=97 Participants
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Worse Eye IOP
Baseline (n=93,95)
|
24.62 mmHg
Standard Deviation 2.475
|
25.12 mmHg
Standard Deviation 2.178
|
|
Change From Baseline in Mean Worse Eye IOP
Change from Baseline at Week 1 (n=91,89)
|
-10.18 mmHg
Standard Deviation 3.149
|
-8.90 mmHg
Standard Deviation 3.044
|
|
Change From Baseline in Mean Worse Eye IOP
Change from Baseline at Week 2 (n=88,93)
|
-10.40 mmHg
Standard Deviation 2.802
|
-9.06 mmHg
Standard Deviation 2.925
|
|
Change From Baseline in Mean Worse Eye IOP
Change from Baseline at Week 4 (n=86,90)
|
-10.06 mmHg
Standard Deviation 2.793
|
-9.21 mmHg
Standard Deviation 2.306
|
|
Change From Baseline in Mean Worse Eye IOP
Change from Baseline at Week 8 (n=88,89)
|
-9.77 mmHg
Standard Deviation 2.852
|
-9.02 mmHg
Standard Deviation 2.869
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12Population: Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.
Outcome measures
| Measure |
Triple Combination Therapy
n=93 Participants
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=97 Participants
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Mean Worse Eye IOP
Week 1 (n=91,90)
|
14.43 mmHg
Standard Deviation 2.785
|
16.23 mmHg
Standard Deviation 2.968
|
|
Mean Worse Eye IOP
Week 2 (n=88,95)
|
14.05 mmHg
Standard Deviation 2.634
|
16.08 mmHg
Standard Deviation 2.726
|
|
Mean Worse Eye IOP
Week 4 (n=86,92)
|
14.38 mmHg
Standard Deviation 2.587
|
15.96 mmHg
Standard Deviation 2.705
|
|
Mean Worse Eye IOP
Week 8 (n=88,91)
|
14.68 mmHg
Standard Deviation 2.709
|
16.11 mmHg
Standard Deviation 2.935
|
|
Mean Worse Eye IOP
Week 12 (n=86,88)
|
14.43 mmHg
Standard Deviation 2.344
|
15.92 mmHg
Standard Deviation 2.867
|
Adverse Events
Triple Combination Therapy
Serious events: 3 serious events
Other events: 57 other events
Deaths: 0 deaths
Combigan®
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triple Combination Therapy
n=93 participants at risk
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=98 participants at risk
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
1.1%
1/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
0.00%
0/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
0.00%
0/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pyomyositis
|
1.1%
1/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
0.00%
0/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
1.1%
1/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
0.00%
0/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Triple Combination Therapy
n=93 participants at risk
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
|
Combigan®
n=98 participants at risk
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
23.7%
22/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
4.1%
4/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Eye irritation
|
14.0%
13/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
4.1%
4/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Dry eye
|
10.8%
10/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
2.0%
2/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Eye pruritus
|
6.5%
6/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
2.0%
2/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Somnolence
|
5.4%
5/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
8.2%
8/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Visual field defect
|
5.4%
5/93
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
5.1%
5/98
The Safety Population, all participants who received at least one dose of study drug and had at least one post-baseline visit, was used to assess Serious Adverse Events and Adverse Events.
|
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. No documents containing confidential information from the sponsor or information developed will be submitted for publication without prior written authorization from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER