Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Bimatoprost SR 15 μg Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
|
Experimental: Bimatoprost SR 10 μg Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
|
Active Comparator: Timolol 0.5%: Comparator Both Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.
Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) [Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
- IOP in the Study Eye at Week 2 (Hour 0) [Week 2 (Hour 0)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- IOP in the Study Eye at Week 2 (Hour 2) [Week 2 (Hour 2)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- IOP in the Study Eye at Week 6 (Hour 0) [Week 6 (Hour 0)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- IOP in the Study Eye at Week 6 (Hour 2) [Week 6 (Hour 2)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- IOP in the Study Eye at Week 12 (Hour 0) [Week 12 (Hour 0)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
- IOP in the Study Eye at Week 12 (Hour 2) [Week 12 (Hour 2)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Secondary Outcome Measures
- Change From Baseline in IOP in the Study Eye [Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)]
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Exclusion Criteria:
-
Previous enrollment in another Allergan Bimatoprost SR Study
-
Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
-
Anticipated need for laser eye surgery within the first 52 weeks of the study duration
-
History of glaucoma surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Eye Center South | Dothan | Alabama | United States | 36301 |
2 | Arizona Eye Center | Chandler | Arizona | United States | 85224 |
3 | Vold Vision | Fayetteville | Arkansas | United States | 72704 |
4 | Mark B. Kislinger, MD, Inc. | Glendora | California | United States | 91741 |
5 | Inland Eye Specialists | Hemet | California | United States | 92545 |
6 | Southern California Eye Physicians and Surgeons | Los Alamitos | California | United States | 90720 |
7 | Eye Research Foundation | Newport Beach | California | United States | 92663 |
8 | North Bay Eye Associates, Inc. | Petaluma | California | United States | 94954 |
9 | Shasta Eye Medical Group, Inc. | Redding | California | United States | 96002 |
10 | University of California (UCSF) Department of Ophthalmology | San Francisco | California | United States | 94143 |
11 | Pacific Eye Surgeons | San Luis Obispo | California | United States | 93401 |
12 | Shepard Eye Center | Santa Maria | California | United States | 93454 |
13 | East West Eye Institute | Torrance | California | United States | 90505 |
14 | Wolstan & Goldberg Eye Associates | Torrance | California | United States | 90505 |
15 | University of Colorado | Aurora | Colorado | United States | 80045 |
16 | Insight Vision Group | Parker | Colorado | United States | 80134 |
17 | Danbury Eye Physicians and Surgeons PC | Danbury | Connecticut | United States | 06810 |
18 | Argus Research at Cape Coral Eye Center | Cape Coral | Florida | United States | 33904 |
19 | Specialty Retinal Center | Coral Springs | Florida | United States | 33067 |
20 | Bruce A Segal, M.D. | Delray Beach | Florida | United States | 33484 |
21 | Eye Associates of Fort Myers | Fort Myers | Florida | United States | 33901 |
22 | Eye Clinic at Shands Medical Plaza | Gainesville | Florida | United States | 32608 |
23 | Bascom Palmer Eye Institute, University of Miami | Palm Beach Gardens | Florida | United States | 33418 |
24 | Center for Sight | Sarasota | Florida | United States | 34239 |
25 | MedEye Associates | South Miami | Florida | United States | 33143-3693 |
26 | Emory University Eye Center | Atlanta | Georgia | United States | 30322 |
27 | Virdi Eye Clinic | Rock Island | Illinois | United States | 61201 |
28 | Kentuckiana Institute for Eye Research at Bennett & Bloom Eye Centers White House Office Complex | Louisville | Kentucky | United States | 40215 |
29 | Johns Hopkins School of Medicine, Wilmer Eye Institute | Baltimore | Maryland | United States | 21287 |
30 | Clinical Eye Research of Boston, Co. | Winchester | Massachusetts | United States | 01890 |
31 | Tekwani Vision Center | Saint Louis | Missouri | United States | 63128 |
32 | Rutgers-New Jersey Medical School | Newark | New Jersey | United States | 07103 |
33 | Eye Associates of New Mexico | Albuquerque | New Mexico | United States | 87109 |
34 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
35 | Alterman, Modi & Wolter | Poughkeepsie | New York | United States | 12603 |
36 | South Shore Eye Care, LLP | Wantagh | New York | United States | 11793 |
37 | Charlotte Eye Ear Nose & Throat Associates, PA | Charlotte | North Carolina | United States | 28210 |
38 | James D. Branch, MD | Winston-Salem | North Carolina | United States | 27101 |
39 | Bergstrom Eye and Laser Clinic | Fargo | North Dakota | United States | 58103 |
40 | Legacy Good Samaritan Hospital - Devers Eye Institute | Portland | Oregon | United States | 97210 |
41 | Lehigh Valley Eye Center, P.C. | Allentown | Pennsylvania | United States | 18104 |
42 | Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | United States | 16006 |
43 | Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
44 | University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
45 | Alkek Eye Center | Houston | Texas | United States | 77030 |
46 | DCT-Shah Research, LLC dba Discovery ClinicalTrials | Mission | Texas | United States | 78572 |
47 | Key Whitman Eye Center | Plano | Texas | United States | 75093 |
48 | Vistar Eye Center | Roanoke | Virginia | United States | 24016 |
49 | Specialty Eyecare Centre | Bellevue | Washington | United States | 98004 |
50 | Wenatchee valley Hospital & Clinics, Clinical research department | Wenatchee | Washington | United States | 98801 |
51 | The Eye Centers of Racine and Kenosha | Racine | Wisconsin | United States | 53405 |
52 | Instituto Oftalmologico de Buenos Aires Oftalmos | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1120AAN |
53 | Hospital Italiano de Buenos Aires - Hospital | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1181ACH |
54 | Clinica Privada de Ojos | Mar del Plata | Buenos Aires | Argentina | 7600 |
55 | Hospital Universitario Austral | Pilar | Buenos Aires | Argentina | B1629ODT |
56 | Centro Medico Oftalmologia Global | Rosario | Santa Fe | Argentina | 2000 |
57 | Centro Médico Grupo Laser Visión | Rosario | Santa Fe | Argentina | S2000AZH |
58 | Organización Médica de Investigación | Ciudad Autónoma de BuenosAires | Argentina | C1015ABO | |
59 | Oftar Centro Privado de Oftalmologia | Mendoza | Argentina | 5500 | |
60 | ACS Crichton Prof. Corp | Calgary | Alberta | Canada | T3E-7M8 |
61 | Nova Scotia Health Authority, Department of Ophthalmology & Visual Sciences | Halifax | Nova Scotia | Canada | B3H 2Y9 |
62 | Trimed Eye Center | Barrie | Ontario | Canada | L4M455 |
63 | Uptown Eye Specialists | Concord | Ontario | Canada | L4K225 |
64 | Galen Eye Centre | Kingston | Ontario | Canada | K7K 6Z6 |
65 | Ophthalmic Consultant Centres Inc | Mississauga | Ontario | Canada | L4W1W9 |
66 | Sunnybrook Research Institute | Toronto | Ontario | Canada | M4N3M5 |
67 | Institut De L'Oeil Des Laurentides | Boisbriand | Quebec | Canada | J7J 2BJ |
68 | Clinique d' ophtalmologie Dr Saurel | Drummondville | Quebec | Canada | J2C 2C4 |
69 | Bellevue Clinic | Montreal | Quebec | Canada | H1V 1GS |
70 | GOGiunta Ophtalmologie | Sherbrooke | Quebec | Canada | J1G 2V4 |
71 | Clinica de Oftalmologia Sandiego S.A. | Medellin | Antioquia | Colombia | 0000 |
72 | Fundación Oftalmologica Nacional Fundonal | Bogota | Distrito Capital De Bogota | Colombia | 110231 |
73 | Fundacion Oftalmologica de Santander Foscal | Floridablanca | Santander | Colombia | 680004 |
74 | Instituto de Investigaciones, Centro Médico Imbanaco de Cali S.A. | Cali | Colombia | 760001 | |
75 | Ocni klinika | Brno | Jihlavska | Czechia | 62500 |
76 | Nemocnicni Lekarna | Hradec Kralove | Sokolska | Czechia | 50005 |
77 | Ocni klinika Pardubice | Prague | Czechia | 53002 | |
78 | Menoufia University Hospital | Shibīn al-Kawm | Cairo | Egypt | 32111 |
79 | Al Kasr Al Ainy Cairo University Hospital | Cairo | Egypt | 11562 | |
80 | Ain Shams University Hospital | Cairo | Egypt | 11566 | |
81 | Klinikum der Universität Regensburg | Regensburg | Bayern | Germany | 93053 |
82 | Augen Zentrum Nordwest | Ahaus | Nordrhein-Westfalen | Germany | 48683 |
83 | Augenärzte am St. Franziskus-Hospital | Munster | Nordrhein-Westfalen | Germany | 48145 |
84 | Universitätsklinik Magdeburg | Magdeburg | Sachsen-Anhalt | Germany | 39120 |
85 | Klinisches Studienzentrum | Mainz | Germany | 55131 | |
86 | Università degli Studi G. D'Annunzio Chieti-Pescara | Chieti | Abruzzo | Italy | 66013 |
87 | Azienda Ospedaliera-Polo Universitario San Paolo | Milano | Lombardia | Italy | 20142 |
88 | Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | Sicilia | Italy | 95123 |
89 | Oculistica Universitaria Università Degli Studi di Pisa - Ospedale di Cisanello Pisa | Pisa | Toscana | Italy | 56124 |
90 | Unità Operativa di Oculistica Ospedale San Raffaele S.r.l. | Milano | Italy | 20132 | |
91 | Ospedale Santa Maria Della Misericordia | Perugia | Italy | 06156 | |
92 | Seoul National University Hospital | Seoul | Korea, Republic of | 110744 | |
93 | Samsung Medical Center | Seoul | Korea, Republic of | 135710 | |
94 | Asan Medical Center | Seoul | Korea, Republic of | 138736 | |
95 | Hospital Kuala Lumpur Jalan Pahang, Department of Opthalmology | Cheras | Kuala Lumpur | Malaysia | 50586 |
96 | Capital Eye Specialists | Wellington | New Zealand | 06011 | |
97 | National University Hospital | Singapore | Singapore | 119074 | |
98 | Singapore National Eye Centre | Singapore | Singapore | 168751 | |
99 | Changi General Hospital | Singapore | Singapore | 529889 | |
100 | Horizon Eye Care Centre | Bloemfontein | Free State | South Africa | 9301 |
101 | Pretoria Eye Institute | Arcadia | Pretoria | South Africa | 0083 |
102 | Eskisehir Osmangazi Universitesi Goz Hastaliklari Anabilim Dali | Meselik | Eskisehir | Turkey | 26480 |
103 | Marmara Universitesi Pendik Egitim Arastirma Hastanesi Goz Hastaliklari | Pendik | Istanbul | Turkey | 34890 |
104 | Celal Bayar Universitesi Tip Fakultesi Goz Hastaliklari Anabilim Dali | Manisa | Turkey | 45030 | |
105 | Addenbrookes Hospital | Cambridge | United Kingdom | CB2 0QQ | |
106 | Queen Alexandra Hospital | Cosham | United Kingdom | PO6 3LY | |
107 | Princess Alexandra Eye Pavilion | Edinburgh | United Kingdom | EH3 9HA | |
108 | James Paget University Hosp NHS Foundation Trust | Great Yarmouth | United Kingdom | NR31 6LA | |
109 | St Paul's Eye Unit Royal Liverpool&Broadgreen, NHS Trust | Liverpool | United Kingdom | L7 8XP | |
110 | Aintree University Hospital NHS Foundation Trust | Liverpool | United Kingdom | L9 7AL | |
111 | ICORG | London | United Kingdom | 153-173 | |
112 | In Patient Pharmacy, Ground Floor, Lambeth Wing St Thomas' Hospital | London | United Kingdom | SE1 7EH | |
113 | Peterborough City Hospital Research and Development Department | Peterborough | United Kingdom | PE39GZ |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Margot Goodkin, Allergan
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 192024-092
- 2014-003186-24
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Period Title: Treatment Period 1 (Day 1 to Week 15) | |||
STARTED | 176 | 176 | 176 |
Received Sham or Bimatoprost SR | 176 | 175 | 173 |
COMPLETED | 172 | 170 | 165 |
NOT COMPLETED | 4 | 6 | 11 |
Period Title: Treatment Period 1 (Day 1 to Week 15) | |||
STARTED | 165 | 168 | 165 |
COMPLETED | 159 | 162 | 160 |
NOT COMPLETED | 6 | 6 | 5 |
Period Title: Treatment Period 1 (Day 1 to Week 15) | |||
STARTED | 147 | 156 | 159 |
COMPLETED | 138 | 152 | 154 |
NOT COMPLETED | 9 | 4 | 5 |
Baseline Characteristics
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | Total |
---|---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Total of all reporting groups |
Overall Participants | 176 | 176 | 176 | 528 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
63.8
(10.7)
|
62.5
(12.7)
|
61.4
(12.4)
|
62.6
(12.0)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
91
51.7%
|
90
51.1%
|
88
50%
|
269
50.9%
|
Male |
85
48.3%
|
86
48.9%
|
88
50%
|
259
49.1%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
116
65.9%
|
115
65.3%
|
104
59.1%
|
335
63.4%
|
Black or African and American |
19
10.8%
|
20
11.4%
|
36
20.5%
|
75
14.2%
|
Asian |
6
3.4%
|
11
6.3%
|
13
7.4%
|
30
5.7%
|
Hispanic |
27
15.3%
|
22
12.5%
|
21
11.9%
|
70
13.3%
|
Other |
8
4.5%
|
8
4.5%
|
2
1.1%
|
18
3.4%
|
Intraocular Pressure (IOP) (millimeters of mercury (mmHg)) [Mean (Full Range) ] | ||||
Hour 0 |
24.39
|
24.28
|
24.46
|
24.38
|
Hour 2 |
23.41
|
23.24
|
23.43
|
23.36
|
Outcome Measures
Title | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Time Frame | Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 176 | 176 | 176 |
Change from Baseline at Week 12, Hour 0 |
-6.47
(0.30)
|
-6.18
(0.30)
|
-6.11
(0.30)
|
Change from Baseline at Week 12, Hour 2 |
-7.16
(0.28)
|
-6.72
(0.28)
|
-6.36
(0.29)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.3738 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.36 | |
Confidence Interval |
(2-Sided) 95% -1.17 to 0.44 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.8514 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.08 | |
Confidence Interval |
(2-Sided) 95% -0.88 to 0.73 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0401 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.80 | |
Confidence Interval |
(2-Sided) 95% -1.57 to -0.04 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.3621 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.36 | |
Confidence Interval |
(2-Sided) 95% -1.12 to 0.41 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 2 (Hour 0) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 2 (Hour 0) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 170 | 172 | 172 |
Least Squares Mean (Standard Error) [mmHg] |
16.74
(0.27)
|
16.92
(0.27)
|
17.50
(0.27)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0382 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.76 | |
Confidence Interval |
() 95% -1.48 to -0.04 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.1133 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.58 | |
Confidence Interval |
() 95% -1.29 to 0.14 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 2 (Hour 2) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 2 (Hour 2) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 170 | 172 | 172 |
Least Squares Mean (Standard Error) [mmHg] |
16.09
(0.25)
|
16.48
(0.25)
|
17.19
(0.25)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0013 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -1.10 | |
Confidence Interval |
() 95% -1.76 to -0.43 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0364 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.71 | |
Confidence Interval |
() 95% -1.38 to -0.05 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 6 (Hour 0) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 6 (Hour 0) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 172 | 171 | 168 |
Least Squares Mean (Standard Error) [mmHg] |
17.05
(0.28)
|
16.93
(0.28)
|
17.51
(0.29)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.2304 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.46 | |
Confidence Interval |
() 95% -1.22 to 0.29 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.1272 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.59 | |
Confidence Interval |
() 95% -1.34 to 0.17 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 6 (Hour 2) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 6 (Hour 2) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 172 | 171 | 168 |
Least Squares Mean (Standard Error) [mmHg] |
16.13
(0.26)
|
16.53
(0.26)
|
17.18
(0.27)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0038 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -1.05 | |
Confidence Interval |
() 95% -1.76 to -0.34 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0741 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.65 | |
Confidence Interval |
() 95% -1.36 to 0.06 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 12 (Hour 0) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 12 (Hour 0) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 168 | 169 | 166 |
Least Squares Mean (Standard Error) [mmHg] |
17.39
(0.30)
|
17.68
(0.30)
|
17.75
(0.30)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.3738 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.36 | |
Confidence Interval |
() 95% -1.17 to 0.44 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.8514 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.08 | |
Confidence Interval |
() 95% -0.88 to 0.73 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
Estimation Comments |
Title | IOP in the Study Eye at Week 12 (Hour 2) |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. |
Time Frame | Week 12 (Hour 2) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 168 | 169 | 166 |
Least Squares Mean (Standard Error) [mmHg] |
16.70
(0.28)
|
17.15
(0.28)
|
17.50
(0.29)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0401 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.80 | |
Confidence Interval |
() 95% -1.57 to -0.04 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Non-Inferiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.3621 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.36 | |
Confidence Interval |
(2-Sided) 95% -1.12 to 0.41 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.39 |
|
Estimation Comments |
Title | Change From Baseline in IOP in the Study Eye |
---|---|
Description | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Time Frame | Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2) |
Outcome Measure Data
Analysis Population Description |
---|
Participants from the ITT Population, all randomized participants, with data available for analyses. |
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
---|---|---|---|
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
Measure Participants | 176 | 176 | 176 |
Change from Baseline at Week 2, Hour 0 |
-7.12
(0.27)
|
-6.94
(0.27)
|
-6.36
(0.27)
|
Change from Baseline at Week 2, Hour 2 |
-7.77
(0.25)
|
-7.38
(0.25)
|
-6.67
(0.25)
|
Change from Baseline at Week 6, Hour 0 |
-6.81
(0.28)
|
-6.93
(0.28)
|
-6.35
(0.29)
|
Change from Baseline at Week 6, Hour 2 |
-7.74
(0.26)
|
-7.33
(0.26)
|
-6.69
(0.27)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0382 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.76 | |
Confidence Interval |
(2-Sided) 95% -1.48 to -0.04 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.1133 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.58 | |
Confidence Interval |
(2-Sided) 95% -1.29 to 0.14 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0013 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -1.10 | |
Confidence Interval |
(2-Sided) 95% -1.76 to -0.43 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0364 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.71 | |
Confidence Interval |
(2-Sided) 95% -1.38 to -0.05 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.2304 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.46 | |
Confidence Interval |
(2-Sided) 95% -1.22 to 0.29 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.1272 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.59 | |
Confidence Interval |
(2-Sided) 95% -1.34 to 0.17 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.38 |
|
Estimation Comments |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 15 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0038 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -1.05 | |
Confidence Interval |
(2-Sided) 95% -1.76 to -0.34 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Bimatoprost SR 10 μg, Timolol 0.5%: Comparator |
---|---|---|
Comments | Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was <0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12). | |
Type of Statistical Test | Superiority | |
Comments | MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used. | |
Statistical Test of Hypothesis | p-Value | 0.0741 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | Least-squares Mean Difference |
Estimated Value | -0.65 | |
Confidence Interval |
(2-Sided) 95% -1.36 to 0.06 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Adverse Events
Time Frame | First dose of study drug to last visit (Up to approximately 20 months) | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | All-cause Mortality: Intent-to-treat Population included all randomized participants. Serious and Other Adverse Events (AEs): Safety Population included all participants who received at least 1 administration of study treatment. Ocular AEs reported for Eye Disorders were collected for each eye (study eye or non-study eye [fellow-eye]) separately. The AE footnotes are used to report the number of AEs that occurred in the study eye and in the fellow (non-study) eye. | |||||
Arm/Group Title | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | |||
Arm/Group Description | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | |||
All Cause Mortality |
||||||
Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/176 (0.6%) | 0/176 (0%) | 1/176 (0.6%) | |||
Serious Adverse Events |
||||||
Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 36/176 (20.5%) | 22/175 (12.6%) | 16/173 (9.2%) | |||
Cardiac disorders | ||||||
Atrial fibrillation | 1/176 (0.6%) | 1/175 (0.6%) | 0/173 (0%) | |||
Myocardial infarction | 1/176 (0.6%) | 0/175 (0%) | 1/173 (0.6%) | |||
Angina pectoris | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Angina unstable | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Coronary artery disease | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Supraventricular tachycardia | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Cardiac failure congestive | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Mitral valve incompetence | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Ear and labyrinth disorders | ||||||
Sudden hearing loss | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Eye disorders | ||||||
Corneal endothelial cell loss | 9/176 (5.1%) | 3/175 (1.7%) | 0/173 (0%) | |||
Corneal oedema | 2/176 (1.1%) | 1/175 (0.6%) | 0/173 (0%) | |||
Macular oedema | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Pterygium | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Corneal decompensation | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Retinal detachment | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Visual impairment | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Retinal tear | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Gastrointestinal disorders | ||||||
Ascites | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Pancreatitis | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Rectal haemorrhage | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Vomiting | 0/176 (0%) | 0/175 (0%) | 2/173 (1.2%) | |||
Diverticular perforation | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Nausea | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
General disorders | ||||||
Death | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Hepatobiliary disorders | ||||||
Cholangitis acute | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Cholelithiasis | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Immune system disorders | ||||||
Sarcoidosis | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Infections and infestations | ||||||
Pneumonia | 3/176 (1.7%) | 0/175 (0%) | 0/173 (0%) | |||
Appendicitis | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Jaw fracture | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Procedural pain | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Fall | 0/176 (0%) | 2/175 (1.1%) | 0/173 (0%) | |||
Hip fracture | 0/176 (0%) | 1/175 (0.6%) | 1/173 (0.6%) | |||
Femur fracture | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Humerus fracture | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Rib fracture | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Subdural haematoma | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Product administered at inappropriate site | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Metabolism and nutrition disorders | ||||||
Diabetes mellitus inadequate control | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Hypoglycaemia | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Hyperkalaemia | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Metabolic acidosis | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Osteoarthritis | 3/176 (1.7%) | 0/175 (0%) | 0/173 (0%) | |||
Rhabdomyolysis | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Haemarthrosis | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Prostate cancer | 2/85 (2.4%) | 0/85 (0%) | 1/88 (1.1%) | |||
Basal cell carcinoma | 2/176 (1.1%) | 0/175 (0%) | 0/173 (0%) | |||
Breast cancer stage I | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Hepatocellular carcinoma | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Metastases to liver | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Metastases to lung | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Natural killer-cell leukaemia | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Squamous cell carcinoma of skin | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Waldenstrom's macroglobulinaemia | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Bronchial carcinoma | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Oropharyngeal squamous cell carcinoma | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Follicular thyroid cancer | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Small intestine carcinoma metastatic | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Squamous cell carcinoma | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Nervous system disorders | ||||||
Encephalopathy | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Transient ischaemic attack | 0/176 (0%) | 2/175 (1.1%) | 0/173 (0%) | |||
Ischaemic stroke | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
VIth nerve paralysis | 1/176 (0.6%) | 0/175 (0%) | 0/173 (0%) | |||
Psychiatric disorders | ||||||
Bipolar disorder | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Depression | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Schizophrenia | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Renal and urinary disorders | ||||||
End stage renal disease | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Acute kidney injury | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Micturition urgency | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Nephrolithiasis | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Reproductive system and breast disorders | ||||||
Menorrhagia | 0/91 (0%) | 1/90 (1.1%) | 0/85 (0%) | |||
Ovarian cyst | 0/91 (0%) | 1/90 (1.1%) | 0/85 (0%) | |||
Vascular disorders | ||||||
Aortic stenosis | 0/176 (0%) | 1/175 (0.6%) | 0/173 (0%) | |||
Penetrating aortic ulcer | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Peripheral arterial occlusive disease | 0/176 (0%) | 0/175 (0%) | 1/173 (0.6%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 133/176 (75.6%) | 103/175 (58.9%) | 72/173 (41.6%) | |||
Eye disorders | ||||||
Conjunctival hyperaemia | 73/176 (41.5%) | 48/175 (27.4%) | 20/173 (11.6%) | |||
Corneal endothelial cell loss | 38/176 (21.6%) | 12/175 (6.9%) | 2/173 (1.2%) | |||
Eye pain | 23/176 (13.1%) | 12/175 (6.9%) | 9/173 (5.2%) | |||
Corneal oedema | 21/176 (11.9%) | 5/175 (2.9%) | 0/173 (0%) | |||
Foreign body sensation in eyes | 19/176 (10.8%) | 18/175 (10.3%) | 2/173 (1.2%) | |||
Dry eye | 18/176 (10.2%) | 12/175 (6.9%) | 7/173 (4%) | |||
Conjunctival haemorrhage | 17/176 (9.7%) | 20/175 (11.4%) | 15/173 (8.7%) | |||
Punctate keratitis | 14/176 (8%) | 10/175 (5.7%) | 8/173 (4.6%) | |||
Photophobia | 13/176 (7.4%) | 13/175 (7.4%) | 0/173 (0%) | |||
Eye irritation | 13/176 (7.4%) | 10/175 (5.7%) | 9/173 (5.2%) | |||
Anterior chamber cell | 13/176 (7.4%) | 6/175 (3.4%) | 1/173 (0.6%) | |||
Ocular discomfort | 11/176 (6.3%) | 3/175 (1.7%) | 1/173 (0.6%) | |||
Iritis | 9/176 (5.1%) | 8/175 (4.6%) | 0/173 (0%) | |||
Lacrimation increased | 9/176 (5.1%) | 7/175 (4%) | 1/173 (0.6%) | |||
Vision blurred | 7/176 (4%) | 11/175 (6.3%) | 1/173 (0.6%) | |||
Blepharitis | 7/176 (4%) | 10/175 (5.7%) | 5/173 (2.9%) | |||
Infections and infestations | ||||||
Nasopharyngitis | 9/176 (5.1%) | 12/175 (6.9%) | 14/173 (8.1%) | |||
Investigations | ||||||
Intraocular pressure increased | 17/176 (9.7%) | 15/175 (8.6%) | 6/173 (3.5%) |
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 |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- 192024-092
- 2014-003186-24