Trial Outcomes & Findings for Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT01915940)
NCT ID: NCT01915940
Last Updated: 2018-04-20
Results Overview
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
COMPLETED
PHASE2
169 participants
Baseline (Day 0) to Week 2
2018-04-20
Participant Flow
Participant milestones
| Measure |
Washout + Placebo Ocular Insert
Glaucoma medication washout and placebo ocular insert in each eye for at least 4 weeks.
|
13 mg Bimatoprost Ocular Insert
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|---|
|
Pre-randomization Washout Period
STARTED
|
169
|
0
|
0
|
|
Pre-randomization Washout Period
COMPLETED
|
130
|
0
|
0
|
|
Pre-randomization Washout Period
NOT COMPLETED
|
39
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
64
|
66
|
|
Treatment Period
COMPLETED
|
0
|
53
|
62
|
|
Treatment Period
NOT COMPLETED
|
0
|
11
|
4
|
Reasons for withdrawal
| Measure |
Washout + Placebo Ocular Insert
Glaucoma medication washout and placebo ocular insert in each eye for at least 4 weeks.
|
13 mg Bimatoprost Ocular Insert
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|---|
|
Pre-randomization Washout Period
Not Qualified for Randomization
|
39
|
0
|
0
|
|
Treatment Period
Decision of Participant
|
0
|
1
|
3
|
|
Treatment Period
Adverse Event
|
0
|
9
|
1
|
|
Treatment Period
Other Miscellaneous Reasons
|
0
|
1
|
0
|
Baseline Characteristics
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
13 mg Bimatoprost Ocular Insert
n=64 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=66 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
66.3 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 2Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Baseline (T=2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Change from Baseline to Week 2 (T=0 hour)
|
-6.40 mm Hg
Standard Error 0.41
|
-6.30 mm Hg
Standard Error 0.41
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Change from Baseline to Week 2 (T=2 hour)
|
-5.20 mm Hg
Standard Error 0.34
|
-5.59 mm Hg
Standard Error 0.41
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Change from Baseline to Week 2 (T=8 hour)
|
-4.21 mm Hg
Standard Error 0.35
|
-4.96 mm Hg
Standard Error 0.37
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 6Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Baseline (T=2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Change from Baseline to Week 6 (T=2 hour)
|
-4.70 mm Hg
Standard Error 0.31
|
-5.40 mm Hg
Standard Error 0.39
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Change from Baseline to Week 6 (T=8 hour)
|
-3.78 mm Hg
Standard Error 0.34
|
-4.42 mm Hg
Standard Error 0.39
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Change from Baseline to Week 6 (T=0 hour)
|
-5.47 mm Hg
Standard Error 0.40
|
-6.41 mm Hg
Standard Error 0.41
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 12Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Change from Baseline to Week 12 (T=0 hour)
|
-5.26 mm Hg
Standard Error 0.47
|
-6.31 mm Hg
Standard Error 0.43
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Change from Baseline to Week 12 (T=2 hour)
|
-4.26 mm Hg
Standard Error 0.44
|
-5.60 mm Hg
Standard Error 0.43
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Change from Baseline to Week 12 (T=8 hour)
|
-3.99 mm Hg
Standard Error 0.33
|
-5.19 mm Hg
Standard Error 0.35
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Baseline (T=2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Month 4Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in IOP at Month 4
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 4
Baseline (T=2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
|
Change From Baseline in IOP at Month 4
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 4
Change from Baseline to Month 4 (T=0 hour)
|
-5.14 mm Hg
Standard Error 0.43
|
-6.29 mm Hg
Standard Error 0.40
|
|
Change From Baseline in IOP at Month 4
Change from Baseline to Month 4 (T=2 hour)
|
-4.37 mm Hg
Standard Error 0.38
|
-5.26 mm Hg
Standard Error 0.41
|
|
Change From Baseline in IOP at Month 4
Change from Baseline to Month 4 (T=8 hour)
|
-3.84 mm Hg
Standard Error 0.34
|
-5.11 mm Hg
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 5Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in IOP at Month 5
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 5
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 5
Change from Baseline to Month 5 (T=0 hour)
|
-4.28 mm Hg
Standard Error 0.36
|
-6.35 mm Hg
Standard Error 0.41
|
|
Change From Baseline in IOP at Month 5
Baseline (T= 2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
|
Change From Baseline in IOP at Month 5
Change from Baseline to Month 5 (T=2 hour)
|
-3.87 mm Hg
Standard Error 0.39
|
-5.45 mm Hg
Standard Error 0.43
|
|
Change From Baseline in IOP at Month 5
Change from Baseline to Month 5 (T=8 hour)
|
-3.21 mm Hg
Standard Error 0.34
|
-4.47 mm Hg
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Month 6Population: Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
13 mg Bimatoprost Ocular Insert
n=63 Participants
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=64 Participants
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Change From Baseline in IOP at Month 6
Baseline (T=0 hour)
|
24.99 mm Hg
Standard Error 0.29
|
25.34 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 6
Baseline (T=2 hour)
|
23.65 mm Hg
Standard Error 0.31
|
23.75 mm Hg
Standard Error 0.28
|
|
Change From Baseline in IOP at Month 6
Baseline (T=8 hour)
|
22.95 mm Hg
Standard Error 0.29
|
23.16 mm Hg
Standard Error 0.29
|
|
Change From Baseline in IOP at Month 6
Change from Baseline to Month 6 (T=0 hour)
|
-4.58 mm Hg
Standard Error 0.39
|
-5.97 mm Hg
Standard Error 0.42
|
|
Change From Baseline in IOP at Month 6
Change from Baseline to Month 6 (T=2 hour)
|
-3.87 mm Hg
Standard Error 0.42
|
-5.20 mm Hg
Standard Error 0.41
|
|
Change From Baseline in IOP at Month 6
Change from Baseline to Month 6 (T=8 hour)
|
-3.25 mm Hg
Standard Error 0.32
|
-4.24 mm Hg
Standard Error 0.37
|
Adverse Events
13 mg Bimatoprost Ocular Insert
Timolol 0.5% + Placebo Ocular Insert
Serious adverse events
| Measure |
13 mg Bimatoprost Ocular Insert
n=64 participants at risk
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=66 participants at risk
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
1.6%
1/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
0.00%
0/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
1.5%
1/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
1.5%
1/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
Other adverse events
| Measure |
13 mg Bimatoprost Ocular Insert
n=64 participants at risk
Following the washout period, 13 mg Bimatoprost Ocular Insert and placebo eye drops twice a day in each eye for 6 months.
|
Timolol 0.5% + Placebo Ocular Insert
n=66 participants at risk
Following the washout period, timolol ophthalmic solution 0.5% twice a day plus placebo ocular insert in each eye for 6 months.
|
|---|---|---|
|
Eye disorders
Eye discharge
|
10.9%
7/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
10.6%
7/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Eye disorders
Conjunctival hyperaemia
|
14.1%
9/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
3.0%
2/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Eye disorders
Punctate keratitis
|
7.8%
5/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
6.1%
4/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Eye disorders
Eye pruritus
|
6.2%
4/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
1.5%
1/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
3/64 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
7.6%
5/66 • Randomization (Day 0) to the end of study (Up to 6 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.
- Publication restrictions are in place
Restriction type: OTHER