Trial Outcomes & Findings for Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01749904)
NCT ID: NCT01749904
Last Updated: 2018-11-07
Results Overview
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
420 participants
Primary outcome timeframe
8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)
Results posted on
2018-11-07
Participant Flow
Participant milestones
| Measure |
BOL-303259-X
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Timolol
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
|---|---|---|
|
Overall Study
STARTED
|
286
|
134
|
|
Overall Study
COMPLETED
|
264
|
123
|
|
Overall Study
NOT COMPLETED
|
22
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
BOL-303259-X
n=284 Participants
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye during the efficacy phase, and for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
Timolol
n=133 Participants
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye. thereafter these subjects were switched to receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Total
n=417 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
64 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
217 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)Population: Intent-to-treat population with LOCF
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Outcome measures
| Measure |
BOL-303259-X
n=284 Participants
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Timolol
n=133 Participants
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
BOL-303259-X Safety Extension Phase
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Mean IOP
8 am week 2
|
18.61 mm Hg
Standard Deviation 3.544
|
19.84 mm Hg
Standard Deviation 3.651
|
—
|
|
Mean IOP
12 pm week 2
|
18.00 mm Hg
Standard Deviation 3.376
|
19.37 mm Hg
Standard Deviation 3.696
|
—
|
|
Mean IOP
4 pm week 2
|
18.09 mm Hg
Standard Deviation 3.293
|
19.20 mm Hg
Standard Deviation 3.359
|
—
|
|
Mean IOP
8 am week 6
|
18.59 mm Hg
Standard Deviation 3.525
|
19.63 mm Hg
Standard Deviation 3.243
|
—
|
|
Mean IOP
12 pm week 6
|
17.84 mm Hg
Standard Deviation 3.305
|
19.09 mm Hg
Standard Deviation 3.230
|
—
|
|
Mean IOP
4 pm week 6
|
17.82 mm Hg
Standard Deviation 3.513
|
19.09 mm Hg
Standard Deviation 3.492
|
—
|
|
Mean IOP
8 am Month 3
|
18.71 mm Hg
Standard Deviation 3.382
|
19.73 mm Hg
Standard Deviation 2.230
|
—
|
|
Mean IOP
12 pm Month 3
|
17.88 mm Hg
Standard Deviation 3.409
|
19.15 mm Hg
Standard Deviation 3.311
|
—
|
|
Mean IOP
4 pm Month 3
|
17.83 mm Hg
Standard Deviation 3.521
|
19.15 mm Hg
Standard Deviation 3.643
|
—
|
SECONDARY outcome
Timeframe: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).Population: Intent-to-treat population with LOCF
Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
Outcome measures
| Measure |
BOL-303259-X
n=284 Participants
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Timolol
n=133 Participants
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
BOL-303259-X Safety Extension Phase
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Response Rate - IOP ≤ 18 mm Hg
|
65 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).Population: Intent-to-treat with LOCF
Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months
Outcome measures
| Measure |
BOL-303259-X
n=284 Participants
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Timolol
n=133 Participants
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
BOL-303259-X Safety Extension Phase
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Response Rate - IOP Reduction ≥ 25%
|
99 Participants
|
26 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Safety population (analyzed as treated). Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population; one subject randomized to BOL-303259-X received timolol in the efficacy phase and was therefore analyzed as part of the timolol treatment group.
Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.
Outcome measures
| Measure |
BOL-303259-X
n=283 Participants
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
BOL-303259-X: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
Timolol
n=135 Participants
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Timolol: Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
BOL-303259-X: All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
|
BOL-303259-X Safety Extension Phase
n=385 Participants
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Number of Participants With Ocular and Systemic Adverse Events
>/= 1 nonocular AE
|
36 Participants
|
19 Participants
|
62 Participants
|
|
Number of Participants With Ocular and Systemic Adverse Events
>/= 1 ocular (Study eye) AE
|
38 Participants
|
16 Participants
|
46 Participants
|
Adverse Events
BOL-303259-X
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Timolol
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
BOL-303259-X Safety Extension Phase
Serious events: 8 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOL-303259-X
n=283 participants at risk
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.
|
Timolol
n=135 participants at risk
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.
|
BOL-303259-X Safety Extension Phase
n=385 participants at risk
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
torn rotator cuff
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.74%
1/135 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.35%
1/283 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Infections and infestations
Pneumonia
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Nervous system disorders
Dizziness
|
0.35%
1/283 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Injury, poisoning and procedural complications
Spider bite
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.74%
1/135 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrence of breast cancer
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Immune system disorders
Allergic angioedema due to Motrin
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Nervous system disorders
Leg disco-ordination
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Nervous system disorders
Aphasia
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Immune system disorders
Food allergy
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right upper lobe lung cancer
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
Injury, poisoning and procedural complications
Fracture of right femoral neck
|
0.35%
1/283 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
|
General disorders
Dislocation of intraocular lens
|
0.00%
0/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.00%
0/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
0.26%
1/385 • Number of events 1 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
Other adverse events
| Measure |
BOL-303259-X
n=283 participants at risk
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase.
|
Timolol
n=135 participants at risk
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase.
|
BOL-303259-X Safety Extension Phase
n=385 participants at risk
Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
3.9%
11/283 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
2.2%
3/135 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
1.3%
5/385 • 1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled \>/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
|
Additional Information
H. DeCory, Director Medical Affairs
Bausch + Lomb, a division of Valeant Pharmaceuticals
Phone: 585 732-3284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place