Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bimatoprost 0.03% Formulation B Ophthalmic Solution Bimatoprost 0.03% Formulation B Ophthalmic Solution |
Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks
|
| Active Comparator: Bimatoprost 0.03% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution |
Drug: Bimatoprost 0.03% Ophthalmic Solution
One drop administered in each eye, every evening, for 12 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 [Baseline, Week 12]
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
- Average Eye IOP at Week 12 [Baseline, Week 12]
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
- Average Eye IOP at Week 6 [Week 6]
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
- Average Eye IOP at Week 2 [Week 2]
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient has ocular hypertension or glaucoma in both eyes
-
Requires IOP-lowering therapy in each eye
Exclusion Criteria:
-
Active or recurrent eye disease that would interfere with interpretation of study data in either eye
-
History of any eye surgery or laser in either eye within 6 months
-
Required chronic use of other eye medications during the study
-
Anticipated wearing of contact lenses during the study.
-
Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Newport Beach | California | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
- 192024-048
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Period Title: Overall Study | ||
| STARTED | 302 | 295 |
| COMPLETED | 296 | 289 |
| NOT COMPLETED | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | Total |
|---|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | Total of all reporting groups |
| Overall Participants | 302 | 295 | 597 |
| Age, Customized (Number) [Number] | |||
| <45 years |
8
2.6%
|
11
3.7%
|
19
3.2%
|
| Between 45 and 65 years |
159
52.6%
|
134
45.4%
|
293
49.1%
|
| >65 years |
135
44.7%
|
150
50.8%
|
285
47.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
170
56.3%
|
181
61.4%
|
351
58.8%
|
| Male |
132
43.7%
|
114
38.6%
|
246
41.2%
|
Outcome Measures
| Title | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 |
|---|---|
| Description | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial. |
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Measure Participants | 295 | 291 |
| Baseline Hour 0 |
24.90
(2.364)
|
24.86
(2.161)
|
| Baseline Hour 2 |
23.79
(2.992)
|
23.78
(2.753)
|
| Baseline Hour 8 |
22.81
(3.168)
|
22.80
(3.301)
|
| Change from Baseline Hour 0 at Week 12 |
-7.49
(2.900)
|
-7.77
(3.029)
|
| Change from Baseline Hour 2 at Week 12 |
-7.06
(3.333)
|
-7.11
(3.192)
|
| Change from Baseline Hour 8 at Week 12 |
-5.93
(3.432)
|
-6.06
(3.602)
|
| Title | Average Eye IOP at Week 12 |
|---|---|
| Description | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population: all randomized patients. |
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Measure Participants | 302 | 295 |
| Baseline Hour 0 |
24.53
(2.196)
|
24.46
(2.019)
|
| Baseline Hour 2 |
23.30
(2.848)
|
23.26
(2.613)
|
| Baseline Hour 8 |
22.31
(2.974)
|
22.29
(3.110)
|
| Week 12 Hour 0 |
17.25
(2.804)
|
16.96
(2.886)
|
| Week 12 Hour 2 |
16.51
(2.900)
|
16.55
(2.863)
|
| Week 12 Hour 8 |
16.64
(2.820)
|
16.59
(2.735)
|
| Title | Average Eye IOP at Week 6 |
|---|---|
| Description | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population: all randomized patients. |
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Measure Participants | 302 | 295 |
| Week 6 Hour 0 |
17.16
(2.967)
|
17.08
(2.957)
|
| Week 6 Hour 2 |
16.52
(2.855)
|
16.45
(2.766)
|
| Week 6 Hour 8 |
16.56
(2.838)
|
16.32
(2.702)
|
| Title | Average Eye IOP at Week 2 |
|---|---|
| Description | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. |
| Time Frame | Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat Population: all randomized patients. |
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
|---|---|---|
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Measure Participants | 302 | 295 |
| Week 2 Hour 0 |
17.40
(2.732)
|
17.14
(2.677)
|
| Week 2 Hour 2 |
16.68
(2.759)
|
16.43
(2.581)
|
| Week 2 Hour 8 |
16.61
(2.766)
|
16.39
(2.795)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | ||
| Arm/Group Description | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | ||
All Cause Mortality |
||||
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/301 (0.7%) | 5/295 (1.7%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 0/301 (0%) | 1/295 (0.3%) | ||
| General disorders | ||||
| Death | 0/301 (0%) | 1/295 (0.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Spinal Compression Fracture | 1/301 (0.3%) | 0/295 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Ovarian Cancer | 1/301 (0.3%) | 0/295 (0%) | ||
| Transitional Cell Carcinoma | 0/301 (0%) | 1/295 (0.3%) | ||
| Nervous system disorders | ||||
| Convulsion | 0/301 (0%) | 1/295 (0.3%) | ||
| Syncope | 0/301 (0%) | 1/295 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 72/301 (23.9%) | 77/295 (26.1%) | ||
| Eye disorders | ||||
| Conjunctival Hyperaemia | 72/301 (23.9%) | 77/295 (26.1%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
- 192024-048