Trial Outcomes & Findings for Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension (NCT NCT01216943)
NCT ID: NCT01216943
Last Updated: 2013-09-19
Results Overview
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
COMPLETED
PHASE3
126 participants
Baseline, Week 12
2013-09-19
Participant Flow
Participant milestones
| Measure |
Triple Combination Therapy
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
126
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Triple Combination Therapy
n=126 Participants
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
|
|---|---|
|
Age, Customized
<45 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
45 to 65 years
|
84 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Outcome measures
| Measure |
Triple Combination Therapy
n=121 Participants
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
|
|---|---|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Baseline
|
22.35 Millimeters of Mercury (mmHg)
Standard Deviation 3.417
|
|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Change from Baseline at Week 12
|
-3.98 Millimeters of Mercury (mmHg)
Standard Deviation 2.856
|
Adverse Events
Triple Combination Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Triple Combination Therapy
n=121 participants at risk
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
|
|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
16.5%
20/121
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all qualified treated patients.
|
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 30 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