Trial Outcomes & Findings for BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01707381)
NCT ID: NCT01707381
Last Updated: 2018-09-04
Results Overview
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
after 4 weeks of treatment
Results posted on
2018-09-04
Participant Flow
Participant milestones
| Measure |
Timolol Maleate Cross Over to BOL-303259X
Participants first recieved timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Thereafter they received BOL-303259X once in the evening for 4 weeks.
|
BOL-303259-X Crossover to Timolol Maleate
Participants first received BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Thereafter, they received timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
13
|
|
Period 1
COMPLETED
|
10
|
11
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
|
Period 2
STARTED
|
10
|
11
|
|
Period 2
COMPLETED
|
10
|
11
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
Participants who were randomized to receive either latanoprostene ophthalmic solution 0.024% or timolol maleate 0.5%
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Treatment-Naive
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Intent to Treat (ITT) Population:All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment.
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
Outcome measures
| Measure |
Timolol Maleate
n=21 Participants
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
Timolol maleate: Topical ophthalmic solution
|
BOL-303259-X
n=21 Participants
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
BOL-303259-X: Topical ophthalmic solution
|
|---|---|---|
|
24 Hour IOP
|
23.55 mm Hg
Standard Deviation 2.46
|
21.77 mm Hg
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Intent to Treat (ITT): All randomized subjects who received at least one dose of study drug, had a baseline, and at least one post baseline intraocular assessment.
Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.
Outcome measures
| Measure |
Timolol Maleate
n=21 Participants
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
Timolol maleate: Topical ophthalmic solution
|
BOL-303259-X
n=21 Participants
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
BOL-303259-X: Topical ophthalmic solution
|
|---|---|---|
|
24-hour Ocular Perfusion Pressure
OPP (nocturnal)
|
48.4 mm Hg
Standard Deviation 9.4
|
52.5 mm Hg
Standard Deviation 9.5
|
|
24-hour Ocular Perfusion Pressure
OPP (Diurnal supine)
|
54.8 mm Hg
Standard Deviation 7.5
|
55.9 mm Hg
Standard Deviation 7.8
|
|
24-hour Ocular Perfusion Pressure
OPP (Diurnal sitting)
|
43.2 mm Hg
Standard Deviation 5.7
|
45.2 mm Hg
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: ITT population
The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.
Outcome measures
| Measure |
Timolol Maleate
n=21 Participants
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
Timolol maleate: Topical ophthalmic solution
|
BOL-303259-X
n=21 Participants
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
BOL-303259-X: Topical ophthalmic solution
|
|---|---|---|
|
IOP Area Under the Curve Over 24 Hours
|
23.54 mm Hg
Standard Deviation 2.44
|
21.77 mm Hg
Standard Deviation 2.29
|
Adverse Events
Timolol Maleate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BOL-303259-X
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Timolol Maleate
n=23 participants at risk
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
Timolol maleate: Topical ophthalmic solution
|
BOL-303259-X
n=23 participants at risk
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
BOL-303259-X: Topical ophthalmic solution
|
|---|---|---|
|
Eye disorders
Punctate keratitis
|
13.0%
3/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
General disorders
Instillation site erythema
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
General disorders
Instillation site irritations
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
Cardiac disorders
Dizziness
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
Cardiac disorders
Dyspnoea
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
General disorders
hyperhidrosis
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
Investigations
Blood pressure decreased
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
|
Investigations
Heart rate decreased
|
4.3%
1/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
0.00%
0/23 • Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place