Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02250651
Collaborator
(none)
528
113
3
67.2
4.7
0.1

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
  • Drug: Bimatoprost SR
  • Other: Sham: Applicator Without Needle
  • Drug: Active Comparator: Timolol 0.5%
  • Drug: Timolol Vehicle (placebo)
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
528 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Actual Study Start Date :
Dec 15, 2014
Actual Primary Completion Date :
Oct 25, 2018
Actual Study Completion Date :
Jul 22, 2020

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02250651
Other Study ID Numbers:
  • 192024-092
  • 2014-003186-24
First Posted:
Sep 26, 2014
Last Update Posted:
Jul 28, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Primary Outcome
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
4. Primary Outcome
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
5. Primary Outcome
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
6. Primary Outcome
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
7. Primary Outcome
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
8. Secondary Outcome
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

[Not Specified]

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
Email clinicaltrials@allergan.com
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT02250651
Other Study ID Numbers:
  • 192024-092
  • 2014-003186-24
First Posted:
Sep 26, 2014
Last Update Posted:
Jul 28, 2021
Last Verified:
Jun 1, 2021