Trial Outcomes & Findings for A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) (NCT NCT01594970)
NCT ID: NCT01594970
Last Updated: 2014-01-28
Results Overview
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
800 participants
Primary outcome timeframe
Week 12
Results posted on
2014-01-28
Participant Flow
Participant milestones
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
295
|
248
|
257
|
|
Overall Study
COMPLETED
|
220
|
166
|
191
|
|
Overall Study
NOT COMPLETED
|
75
|
82
|
66
|
Reasons for withdrawal
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Non-Adverse Event Related
|
4
|
5
|
6
|
|
Overall Study
Adverse Event
|
17
|
23
|
23
|
|
Overall Study
Lost to Follow-up
|
54
|
54
|
37
|
Baseline Characteristics
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Baseline characteristics by cohort
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=295 Participants
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=248 Participants
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=257 Participants
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 13.23 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 13.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
380 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat: all treated subjects with data at this time point
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
Outcome measures
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=220 Participants
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=166 Participants
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=191 Participants
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
None
|
40 Participants
|
49 Participants
|
20 Participants
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Trace
|
71 Participants
|
54 Participants
|
70 Participants
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Mild
|
73 Participants
|
47 Participants
|
65 Participants
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Moderate
|
31 Participants
|
11 Participants
|
30 Participants
|
|
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Severe
|
5 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Intent to Treat: all treated subjects
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Outcome measures
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=295 Participants
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=248 Participants
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=257 Participants
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP)
Baseline
|
18.6 Millimeters of Mercury (mmHg)
Standard Deviation 5.39
|
17.0 Millimeters of Mercury (mmHg)
Standard Deviation 5.73
|
19.3 Millimeters of Mercury (mmHg)
Standard Deviation 6.19
|
|
Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Week 6 (N=251, 204, 233)
|
-4.7 Millimeters of Mercury (mmHg)
Standard Deviation 4.50
|
-2.6 Millimeters of Mercury (mmHg)
Standard Deviation 4.43
|
-3.2 Millimeters of Mercury (mmHg)
Standard Deviation 5.44
|
|
Change From Baseline in Intraocular Pressure (IOP)
Change from Baseline at Week 12 (N=220, 165, 191)
|
-4.3 Millimeters of Mercury (mmHg)
Standard Deviation 4.42
|
-2.8 Millimeters of Mercury (mmHg)
Standard Deviation 4.68
|
-3.4 Millimeters of Mercury (mmHg)
Standard Deviation 6.11
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Intent to Treat: all treated subjects with data at this time point
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
Outcome measures
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=295 Participants
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=248 Participants
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=257 Participants
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Overall Percent Change From Baseline in IOP
Change from Baseline at Week 6 (N=251, 204, 233)
|
-22.09 Percent Change
Standard Deviation 17.023
|
-12.90 Percent Change
Standard Deviation 18.912
|
-14.37 Percent Change
Standard Deviation 20.883
|
|
Overall Percent Change From Baseline in IOP
Change from Baseline at Week 12 (N=220, 165, 191)
|
-20.22 Percent Change
Standard Deviation 17.566
|
-12.81 Percent Change
Standard Deviation 19.438
|
-14.25 Percent Change
Standard Deviation 23.376
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Intent to Treat: all treated subjects with data at this time point
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.
Outcome measures
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=220 Participants
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=166 Participants
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=191 Participants
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hyperemia Severity in the Study Eye
Improved
|
1 Participants
|
8 Participants
|
15 Participants
|
|
Change From Baseline in Hyperemia Severity in the Study Eye
No Change
|
191 Participants
|
149 Participants
|
159 Participants
|
|
Change From Baseline in Hyperemia Severity in the Study Eye
Worsened
|
28 Participants
|
9 Participants
|
17 Participants
|
Adverse Events
Bimatoprost 0.01% (Naive Monotherapy)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Bimatoprost 0.01% (Switched Monotherapy)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Bimatoprost 0.01% (With Adjunctive Therapy)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=295 participants at risk
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=248 participants at risk
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=257 participants at risk
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Eye disorders
Glaucoma
|
0.00%
0/295
|
0.00%
0/248
|
0.39%
1/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.34%
1/295
|
0.00%
0/248
|
0.00%
0/257
|
Other adverse events
| Measure |
Bimatoprost 0.01% (Naive Monotherapy)
n=295 participants at risk
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
|
Bimatoprost 0.01% (Switched Monotherapy)
n=248 participants at risk
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
|
Bimatoprost 0.01% (With Adjunctive Therapy)
n=257 participants at risk
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
|
|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
2.4%
7/295
|
3.6%
9/248
|
5.4%
14/257
|
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 at least 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