Title

Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    bimatoprost timolol ...
  • Study Participants

    169
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
Study Started
Oct 23
2013
Primary Completion
Sep 30
2014
Study Completion
Nov 14
2014
Results Posted
Apr 20
2018
Last Update
Apr 20
2018

Drug Bimatoprost

Bimatoprost ocular insert

Drug Timolol 0.5%

Timolol 0.5% solution

  • Other names: timoptic

Drug Placebo Eye Drops

Placebo topical eye drops

Device Placebo Ocular Insert

Ocular insert without any active drug

  • Other names: non-medicated (placebo) Ocular Insert

13 mg Bimatoprost Ocular Insert Experimental

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.

Timolol 0.5% + Placebo Ocular Insert Active Comparator

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.

Criteria

Key Inclusion Criteria:

Written informed consent
Primary open-angle glaucoma or ocular hypertension in both eyes
Best-corrected distance vision of 20/80 or better
Stable visual field
corneal thickness between 490-620 micrometers

Key Exclusion Criteria:

Cup-to-disc ratio greater than 0.8
significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
past history of corneal refractive surgery
past history of any incisional surgery for glaucoma at any time
corneal abnormalities that would interfere with tonometry readings
current participation in an investigational drug or device study or participation in such a study within 30 days of screening
Inability to accurately evaluate the retina

Summary

13 mg Bimatoprost Ocular Insert

Timolol 0.5% + Placebo Ocular Insert

All Events

Event Type Organ System Event Term 13 mg Bimatoprost Ocular Insert Timolol 0.5% + Placebo Ocular Insert

Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 2 (T=0 hour)

-6.4
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Week 2 (T=2 hour)

-5.2
mm Hg (Mean)
Standard Error: 0.34

Change from Baseline to Week 2 (T=8 hour)

-4.21
mm Hg (Mean)
Standard Error: 0.35

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 2 (T=0 hour)

-6.3
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Week 2 (T=2 hour)

-5.59
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Week 2 (T=8 hour)

-4.96
mm Hg (Mean)
Standard Error: 0.37

Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 6 (T=0 hour)

-5.47
mm Hg (Mean)
Standard Error: 0.40

Change from Baseline to Week 6 (T=2 hour)

-4.7
mm Hg (Mean)
Standard Error: 0.31

Change from Baseline to Week 6 (T=8 hour)

-3.78
mm Hg (Mean)
Standard Error: 0.34

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 6 (T=0 hour)

-6.41
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Week 6 (T=2 hour)

-5.4
mm Hg (Mean)
Standard Error: 0.39

Change from Baseline to Week 6 (T=8 hour)

-4.42
mm Hg (Mean)
Standard Error: 0.39

Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 12 (T=0 hour)

-5.26
mm Hg (Mean)
Standard Error: 0.47

Change from Baseline to Week 12 (T=2 hour)

-4.26
mm Hg (Mean)
Standard Error: 0.44

Change from Baseline to Week 12 (T=8 hour)

-3.99
mm Hg (Mean)
Standard Error: 0.33

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Week 12 (T=0 hour)

-6.31
mm Hg (Mean)
Standard Error: 0.43

Change from Baseline to Week 12 (T=2 hour)

-5.6
mm Hg (Mean)
Standard Error: 0.43

Change from Baseline to Week 12 (T=8 hour)

-5.19
mm Hg (Mean)
Standard Error: 0.35

Change From Baseline in IOP at Month 4

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 4 (T=0 hour)

-5.14
mm Hg (Mean)
Standard Error: 0.43

Change from Baseline to Month 4 (T=2 hour)

-4.37
mm Hg (Mean)
Standard Error: 0.38

Change from Baseline to Month 4 (T=8 hour)

-3.84
mm Hg (Mean)
Standard Error: 0.34

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 4 (T=0 hour)

-6.29
mm Hg (Mean)
Standard Error: 0.40

Change from Baseline to Month 4 (T=2 hour)

-5.26
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Month 4 (T=8 hour)

-5.11
mm Hg (Mean)
Standard Error: 0.36

Change From Baseline in IOP at Month 5

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T= 2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 5 (T=0 hour)

-4.28
mm Hg (Mean)
Standard Error: 0.36

Change from Baseline to Month 5 (T=2 hour)

-3.87
mm Hg (Mean)
Standard Error: 0.39

Change from Baseline to Month 5 (T=8 hour)

-3.21
mm Hg (Mean)
Standard Error: 0.34

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T= 2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 5 (T=0 hour)

-6.35
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Month 5 (T=2 hour)

-5.45
mm Hg (Mean)
Standard Error: 0.43

Change from Baseline to Month 5 (T=8 hour)

-4.47
mm Hg (Mean)
Standard Error: 0.38

Change From Baseline in IOP at Month 6

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.

13 mg Bimatoprost Ocular Insert

Baseline (T=0 hour)

24.99
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.65
mm Hg (Mean)
Standard Error: 0.31

Baseline (T=8 hour)

22.95
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 6 (T=0 hour)

-4.58
mm Hg (Mean)
Standard Error: 0.39

Change from Baseline to Month 6 (T=2 hour)

-3.87
mm Hg (Mean)
Standard Error: 0.42

Change from Baseline to Month 6 (T=8 hour)

-3.25
mm Hg (Mean)
Standard Error: 0.32

Timolol 0.5% + Placebo Ocular Insert

Baseline (T=0 hour)

25.34
mm Hg (Mean)
Standard Error: 0.29

Baseline (T=2 hour)

23.75
mm Hg (Mean)
Standard Error: 0.28

Baseline (T=8 hour)

23.16
mm Hg (Mean)
Standard Error: 0.29

Change from Baseline to Month 6 (T=0 hour)

-5.97
mm Hg (Mean)
Standard Error: 0.42

Change from Baseline to Month 6 (T=2 hour)

-5.2
mm Hg (Mean)
Standard Error: 0.41

Change from Baseline to Month 6 (T=8 hour)

-4.24
mm Hg (Mean)
Standard Error: 0.37

Total

130
Participants

Age, Continuous

65.6
years (Mean)
Standard Deviation: 9.4

Sex: Female, Male

Pre-randomization Washout Period

Washout + Placebo Ocular Insert

Treatment Period

13 mg Bimatoprost Ocular Insert

Timolol 0.5% + Placebo Ocular Insert

Drop/Withdrawal Reasons

Washout + Placebo Ocular Insert

13 mg Bimatoprost Ocular Insert

Timolol 0.5% + Placebo Ocular Insert