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Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01157364
Collaborator
(none)
109
Enrollment
57
Locations
6
Arms
70.5
Actual Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

Condition or Disease Intervention/Treatment Phase
  • Drug: bimatoprost 20 µg generation 2
  • Drug: bimatoprost 15 µg generation 2
  • Drug: bimatoprost 10 µg generation 2
  • Drug: bimatoprost 6 µg generation 2
  • Drug: bimatoprost 15 µg generation 1
  • Drug: bimatoprost 10 µg generation 1
  • Drug: bimatoprost 0.03%
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date :
Sep 23, 2010
Actual Primary Completion Date :
Jul 27, 2016
Actual Study Completion Date :
Aug 9, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: bimatoprost 20 µg generation 2, bimatoprost 0.03%

Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Drug: bimatoprost 20 µg generation 2
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.

Drug: bimatoprost 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Other Names:
  • LUMIGAN®

    		•
    Other: bimatoprost 15 µg generation 2, bimatoprost 0.03%

    Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

    Drug: bimatoprost 15 µg generation 2
    Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

    Drug: bimatoprost 0.03%
    One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Other Names:
  • LUMIGAN®

    		•
    Other: bimatoprost 10 µg generation 2, bimatoprost 0.03%

    Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

    Drug: bimatoprost 10 µg generation 2
    Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

    Drug: bimatoprost 0.03%
    One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Other Names:
  • LUMIGAN®

    		•
    Other: bimatoprost 6 µg generation 2, bimatoprost 0.03%

    Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

    Drug: bimatoprost 6 µg generation 2
    Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

    Drug: bimatoprost 0.03%
    One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Other Names:
  • LUMIGAN®

    		•
    Other: bimatoprost 15 µg generation 1, bimatoprost 0.03%

    Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

    Drug: bimatoprost 15 µg generation 1
    Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.

    Drug: bimatoprost 0.03%
    One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Other Names:
  • LUMIGAN®

    		•
    Other: bimatoprost 10 µg generation 1, bimatoprost 0.03%

    Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

    Drug: bimatoprost 10 µg generation 1
    Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

    Drug: bimatoprost 0.03%
    One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Other Names:
  • LUMIGAN®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye [Baseline, Month 24]

      IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

    Secondary Outcome Measures

    1. Time-Matched Intraocular Pressure (IOP) in the Study Eye [Baseline to Month 6]

      IOP is a measurement of the fluid pressure inside the study eye.

    2. Mean Diurnal IOP in the Study Eye [Baseline, Month 6]

      IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.

    3. Time to Rescue Treatment or Re-Treatment in the Study Eye [24 Months]

      Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of open angle glaucoma or ocular hypertension
    Exclusion Criteria:

    • Uncontrolled medical conditions

    • Anticipated wearing of contact lenses during the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sall Research Medical Center Artesia California United States 90701
    2 Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego La Jolla California United States 92093
    3 Doheny Eye Institute Los Angeles California United States 90033
    4 Martel Eye Medical Group Rancho Cordova California United States 95670
    5 Shasta Eye Medical Group, Inc. Redding California United States 96002
    6 Grutzmacher and Lewis, Inc. Sacramento California United States 95815
    7 Pacific Eye Surgeons San Luis Obispo California United States 93401
    8 Wolstan & Goldberg Eye Associates Torrance California United States 90505
    9 Specialty Eye Care Parker Colorado United States 80134
    10 The Eye Associates of Manatee Bradenton Florida United States 34209
    11 Emory University, The Emory Eye Center Atlanta Georgia United States 30322
    12 Coastal Research Associates Roswell Georgia United States 30076
    13 Springfield Clinic Springfield Illinois United States 62703
    14 Glaucoma Consultants Baltimore Maryland United States 21204
    15 Tufts Medical Center/New England Eye Center Boston Massachusetts United States 02111
    16 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
    17 ActivMed Practices & Research Methuen Massachusetts United States 01844
    18 Clinical Eye Research of Boston/ Charles River Eye Associates Winchester Massachusetts United States 01890
    19 Moyes Eye Center Kansas City Missouri United States 64154
    20 Northern New Jersey Eye Institute PA South Orange New Jersey United States 07079
    21 Ophthalmic Consultants of Long Island Lynbrook New York United States 11563
    22 Glaucoma Associates of NY New York New York United States 10003
    23 Rochester Ophthalmological Group PC Rochester New York United States 14618
    24 Charlotte Eye Ear Nose & Throat Associates, PA Charlotte North Carolina United States 28210
    25 Cornerstone Eye Care High Point North Carolina United States 27262
    26 James D. Branch, MD Winston-Salem North Carolina United States 27101
    27 Legacy Good Samaritan - Devers Eye Institute Portland Oregon United States 97210
    28 Scott & Christie and Associates Cranberry Township Pennsylvania United States 16066
    29 Philadelphia Eye Associates Philadelphia Pennsylvania United States 19148
    30 Keystone Research LTD Austin Texas United States 78731
    31 Glaucoma Associates of TX Dallas Texas United States 75231
    32 R and R Eye Research San Antonio Texas United States 78229
    33 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
    34 Focus Clinical Research Salt Lake City Utah United States 84107
    35 Spokane Eye Clinical Research Spokane Washington United States 99204
    36 Wenatchee Valley Medical Center Wenatchee Washington United States 98801
    37 Melbourne Eye Specialists Fitzroy Australia 3065
    38 Eye Associates Sydney New South Wales Australia 2000
    39 UZ Leuven, Campus St. Rafael Dienst Oogheelkunde Belgium Leuven 3000
    40 Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia Sao Paulo Brazil 04023-062
    41 A.C. S. Crichton Prof. Corp Calgary Alberta Canada T3E-7M8
    42 Eye Care Center Halifax Nova Scotia Canada B3H 2Y9
    43 Anjema Eye Institute Chatham Ontario Canada N7M 5J7
    44 Galen Eye Centre Kingston Ontario Canada K7K 6Z6
    45 Ivey Eye Institute London Ontario Canada N6A 4V2
    46 Institut de l'œil des Laurentides Boisbriand Quebec Canada J7H 1S6
    47 Clarity Eye Institute Vaughan Canada L4K 0C5
    48 Staedtisches Klinikum Department of Opthalmology Karlsruhe Germany 76133
    49 Kaplan Medical Center Rohovot Israel 76100
    50 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    51 The Sam Rothberg Glaucoma Center, Tel-Hashomer Israel 52621
    52 Asian Eye Institute Makati City Philippines 1200
    53 Pacific Eye and Laser Institute (PELI) Makati City Philippines 1209
    54 St. Lukes Medical Center-Quezon City Metro Manila Philippines Quezon City 1112
    55 Singapore National Eye Center Singapore Singapore 168751
    56 Valles Oftalmologia Recerca, Hospital General de Catalunya, Sant Cugat Spain 08195
    57 Fundacion Oftalmologica Del Mediterraneo Valencia Spain 46015

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01157364
    Other Study ID Numbers:
    • 192024-041D
    • 2011-005091-42
    First Posted:
    Jul 7, 2010
    Last Update Posted:
    Mar 30, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension
    Bimatoprost

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Period Title: Overall Study
    STARTED 15 21 21 18 11 23
    COMPLETED 13 17 17 16 9 22
    NOT COMPLETED 2 4 4 2 2 1

    Baseline Characteristics

    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03% Total
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Total of all reporting groups
    Overall Participants 15 21 21 18 11 23 109
    Age, Customized (Number) [Number]
    <45 years
    1
    6.7%
    2
    9.5%
    0
    0%
    2
    11.1%
    0
    0%
    1
    4.3%
    6
    5.5%
    45-65 years
    6
    40%
    9
    42.9%
    12
    57.1%
    9
    50%
    3
    27.3%
    10
    43.5%
    49
    45%
    >65 years
    8
    53.3%
    10
    47.6%
    9
    42.9%
    7
    38.9%
    8
    72.7%
    12
    52.2%
    54
    49.5%
    Sex: Female, Male (Count of Participants)
    Female
    7
    46.7%
    10
    47.6%
    9
    42.9%
    12
    66.7%
    5
    45.5%
    13
    56.5%
    56
    51.4%
    Male
    8
    53.3%
    11
    52.4%
    12
    57.1%
    6
    33.3%
    6
    54.5%
    10
    43.5%
    53
    48.6%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
    Description IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
    Time Frame Baseline, Month 24

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Measure Participants 15 21 21 18 11 23
    Baseline Hour 0,
    26.57
    (4.144)
    25.14
    (2.967)
    24.48
    (2.112)
    25.14
    (3.609)
    23.73
    (1.664)
    24.22
    (2.104)
    Week 4, Hour 0
    -8.83
    (3.750)
    -7.80
    (2.613)
    -7.18
    (3.250)
    -7.09
    (2.697)
    -5.50
    (3.507)
    -7.33
    (3.006)
    Week 12, Hour 0
    -7.92
    (2.557)
    -7.02
    (3.215)
    -6.82
    (3.024)
    -6.53
    (4.091)
    -5.95
    (3.546)
    -7.00
    (2.899)
    Month 6, Hour 0
    -5.65
    (3.652)
    -6.50
    (2.646)
    -5.38
    (3.015)
    -6.81
    (2.529)
    -3.94
    (4.170)
    -5.40
    (3.106)
    Month 12, Hour 0
    -9.00
    (2.387)
    -5.64
    (2.824)
    -6.00
    (2.881)
    -5.38
    (3.091)
    -5.80
    (4.251)
    -5.71
    (2.138)
    Month 18, Hour 0
    -6.00
    (3.464)
    -6.92
    (2.558)
    -7.70
    (3.493)
    -6.93
    (2.335)
    -4.25
    (0.354)
    -9.75
    (3.182)
    Month 24, Hour 0
    -5.75
    (4.330)
    -7.30
    (2.019)
    -7.40
    (1.557)
    -5.70
    (2.197)
    -8.50
    (NA)
    -5.50
    (NA)
    2. Secondary Outcome
    Title Time-Matched Intraocular Pressure (IOP) in the Study Eye
    Description IOP is a measurement of the fluid pressure inside the study eye.
    Time Frame Baseline to Month 6

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Measure Participants 15 21 21 18 11 23
    Baseline, Hour 0
    26.57
    (4.144)
    25.14
    (2.967)
    24.48
    (2.112)
    25.14
    (3.609)
    23.73
    (1.664)
    24.22
    (2.104)
    Week 4, Hour 0
    17.73
    (3.982)
    17.45
    (2.032)
    17.55
    (3.166)
    17.53
    (2.661)
    18.23
    (4.315)
    17.00
    (2.748)
    Week 12, Hour 0
    17.71
    (2.996)
    18.12
    (3.626)
    17.61
    (2.289)
    18.03
    (3.659)
    17.77
    (2.970)
    17.23
    (2.443)
    Month 6, Hour 0
    19.10
    (3.843)
    17.90
    (3.785)
    19.35
    (2.536)
    17.35
    (2.135)
    19.44
    (3.610)
    18.80
    (3.282)
    3. Secondary Outcome
    Title Mean Diurnal IOP in the Study Eye
    Description IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.
    Time Frame Baseline, Month 6

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Including IOP assessments after rescue or retreatment.
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Measure Participants 15 21 21 18 11 23
    Baseline
    23.38
    (3.967)
    23.74
    (3.411)
    23.02
    (2.011)
    23.54
    (5.121)
    20.84
    (2.123)
    22.09
    (2.521)
    Week 4
    17.10
    (4.584)
    16.59
    (1.884)
    16.40
    (2.529)
    17.35
    (5.810)
    17.89
    (2.038)
    16.88
    (3.782)
    Week 12
    17.34
    (3.608)
    18.22
    (3.294)
    17.33
    (2.274)
    17.29
    (3.199)
    17.12
    (2.211)
    17.06
    (2.604)
    Month 6
    19.79
    (4.498)
    18.51
    (3.539)
    18.94
    (2.879)
    16.71
    (1.879)
    18.13
    (3.080)
    18.55
    (3.632)
    4. Secondary Outcome
    Title Time to Rescue Treatment or Re-Treatment in the Study Eye
    Description Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.
    Time Frame 24 Months

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 μg Generation 1, Bimatoprost 0.03% Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    Measure Participants 15 21 21 18 11 23
    Median (Full Range) [Days]
    328
    265
    273
    391.5
    411
    237

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
    Arm/Group Title Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
    Arm/Group Description Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
    All Cause Mortality
    Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 3/21 (14.3%) 6/21 (28.6%) 4/18 (22.2%) 3/11 (27.3%) 3/23 (13%)
    Blood and lymphatic system disorders
    Thrombocytopenia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Cardiac disorders
    Angina Pectoris 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Atrial Fibrillation 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Atrioventricular Block 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Coronary Artery Disease 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Eye disorders
    Retinal Detachment 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Gastrointestinal disorders
    Duodenitis 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Gastritis 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Large Intestine Polyp 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Gastric Ulcer Haemorrhage 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Hematemesis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    General disorders
    Non-cardiac Chest Pain 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Immune system disorders
    Allergy to Arthropod Sting 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Infections and infestations
    Neutropenic Sepsis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Injury, poisoning and procedural complications
    Cervical Vertebral Fracture 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Osteoarthritis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Gastrointestinal Carcinoma 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Malignant Ascites 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Prostate Cancer 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Tonsil Cancer 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Malignant Melanoma 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Mantle Cell Lymphoma Stage IV 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Nervous system disorders
    Carotid Artery Stenosis 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Dizziness 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Renal and urinary disorders
    Urinary Incontinence 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Other (Not Including Serious) Adverse Events
    Bimatoprost 20 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 2, Bimatoprost 0.03% Bimatoprost 10 µg Generation 2, Bimatoprost 0.03% Bimatoprost 6 µg Generation 2, Bimatoprost 0.03% Bimatoprost 15 µg Generation 1, Bimatoprost 0.03% Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/15 (80%) 16/21 (76.2%) 17/21 (81%) 15/18 (83.3%) 8/11 (72.7%) 21/23 (91.3%)
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Anaemia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Pancytopenia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Splenomegaly 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Thrombocytopenia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Cardiac disorders
    Atrioventricular Block 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Congenital, familial and genetic disorders
    Corneal Dystrophy 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 1/23 (4.3%)
    Endocrine disorders
    Hypothyroidism 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Eye disorders
    Conjunctival Hyperaemia 7/15 (46.7%) 8/21 (38.1%) 7/21 (33.3%) 8/18 (44.4%) 1/11 (9.1%) 7/23 (30.4%)
    Foreign Body Sensation in Eyes 4/15 (26.7%) 2/21 (9.5%) 3/21 (14.3%) 4/18 (22.2%) 2/11 (18.2%) 3/23 (13%)
    Dry Eye 3/15 (20%) 1/21 (4.8%) 1/21 (4.8%) 0/18 (0%) 1/11 (9.1%) 2/23 (8.7%)
    Eye Pain 3/15 (20%) 4/21 (19%) 4/21 (19%) 1/18 (5.6%) 2/11 (18.2%) 3/23 (13%)
    Punctate Keratitis 3/15 (20%) 2/21 (9.5%) 3/21 (14.3%) 2/18 (11.1%) 1/11 (9.1%) 1/23 (4.3%)
    Conjunctival Haemorrhage 2/15 (13.3%) 4/21 (19%) 3/21 (14.3%) 3/18 (16.7%) 1/11 (9.1%) 5/23 (21.7%)
    Growth of Eyelashes 2/15 (13.3%) 1/21 (4.8%) 1/21 (4.8%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Iris Hyperpigmentation 2/15 (13.3%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Photophobia 2/15 (13.3%) 3/21 (14.3%) 4/21 (19%) 0/18 (0%) 2/11 (18.2%) 3/23 (13%)
    Vision Blurred 2/15 (13.3%) 2/21 (9.5%) 2/21 (9.5%) 2/18 (11.1%) 1/11 (9.1%) 3/23 (13%)
    Anterior Chamber Flare 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Blepharospasm 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Cataract 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 1/18 (5.6%) 1/11 (9.1%) 0/23 (0%)
    Conjunctival Oedema 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Conjunctivitis Allergic 1/15 (6.7%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Corneal Disorder 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Erythema of Eyelid 1/15 (6.7%) 1/21 (4.8%) 1/21 (4.8%) 1/18 (5.6%) 0/11 (0%) 2/23 (8.7%)
    Eyelid Margin Crusting 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Eyelid Oedema 1/15 (6.7%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Eyelid Pain 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Eyelid Retraction 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Eyelid Pruritus 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Lacrimation Increased 1/15 (6.7%) 5/21 (23.8%) 3/21 (14.3%) 1/18 (5.6%) 1/11 (9.1%) 4/23 (17.4%)
    Macular Cyst 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Ocular Discomfort 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Optic Disc Haemorrhage 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Retinal Vein Occlusion 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Blepharitis 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Visual Acuity Reduced 0/15 (0%) 1/21 (4.8%) 1/21 (4.8%) 2/18 (11.1%) 2/11 (18.2%) 1/23 (4.3%)
    Anterior Chamber Inflammation 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Corneal Opacity 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Eye Irritation 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 2/23 (8.7%)
    Eye Pruritus 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 4/23 (17.4%)
    Iris Adhesions 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 1/23 (4.3%)
    Lid Margin Discharge 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Orbit Atrophy 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Retinal Detachment 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Corneal Oedema 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 1/23 (4.3%)
    Hyphaema 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 1/23 (4.3%)
    Iritis 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 2/23 (8.7%)
    Lagophthalmos 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Posterior Capsule Opacification 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 1/23 (4.3%)
    Eyelid Ptosis 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 3/23 (13%)
    Vitreous Detachment 0/15 (0%) 1/21 (4.8%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Gastrointestinal disorders
    Diarrhoea 1/15 (6.7%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 2/11 (18.2%) 1/23 (4.3%)
    Large Intestine Polyp 1/15 (6.7%) 1/21 (4.8%) 2/21 (9.5%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Vomiting 1/15 (6.7%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Gastrooesophageal Reflux Disease 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Constipation 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Diverticulum Intestinal 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Dyspepsia 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Gastric Ulcer Haemorrhage 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Inguinal Hernia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Nausea 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Stomatitis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    General disorders
    Chest Pain 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Pyrexia 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Non-cardiac Chest Pain 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Immune system disorders
    Drug Hypersensitivity 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 2/23 (8.7%)
    Allergy to Arthropod Sting 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Infections and infestations
    Nasopharyngitis 3/15 (20%) 1/21 (4.8%) 0/21 (0%) 3/18 (16.7%) 0/11 (0%) 1/23 (4.3%)
    Influenza 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Upper Respiratory Tract Infection 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 1/18 (5.6%) 1/11 (9.1%) 0/23 (0%)
    Conjunctivitis 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 2/18 (11.1%) 1/11 (9.1%) 2/23 (8.7%)
    Pneumonia 0/15 (0%) 0/21 (0%) 0/21 (0%) 2/18 (11.1%) 1/11 (9.1%) 0/23 (0%)
    Sinusitis 0/15 (0%) 0/21 (0%) 0/21 (0%) 2/18 (11.1%) 0/11 (0%) 0/23 (0%)
    Ear Infection 0/15 (0%) 1/21 (4.8%) 1/21 (4.8%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Urinary Tract Infection 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Escherichia Sepsis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Neutropenic Sepsis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Oesophageal Candidiasis 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Progressive Multifocal Leukoencephalopathy 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Injury, poisoning and procedural complications
    Muscle Strain 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Fall 0/15 (0%) 0/21 (0%) 0/21 (0%) 3/18 (16.7%) 0/11 (0%) 0/23 (0%)
    Corneal Abrasion 0/15 (0%) 0/21 (0%) 0/21 (0%) 2/18 (11.1%) 1/11 (9.1%) 0/23 (0%)
    Cervical Vertebral Fracture 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Facial Bones Fracture 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Joint Injury 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Tendon Rupture 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Upper Limb Fracture 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Transfusion Related Complication 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Aqueous Humour Leakage 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 3/23 (13%)
    Investigations
    Intraocular Pressure Increased 4/15 (26.7%) 2/21 (9.5%) 2/21 (9.5%) 1/18 (5.6%) 2/11 (18.2%) 2/23 (8.7%)
    Blood Cholesterol Increased 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Blood Lactate Dehydrogenase Increased 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Blood Pressure Increased 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Gamma-glutamyltransferase Increased 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Blood Glucose Increased 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 1/23 (4.3%)
    Blood Potassium Decreased 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Heart Rate Irregular 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Blood Urine Present 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Metabolism and nutrition disorders
    Dehydration 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 1/11 (9.1%) 0/23 (0%)
    Diabetes Mellitus 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 3/23 (13%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Back Pain 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Musculoskeletal Pain 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Osteoarthritis 0/15 (0%) 0/21 (0%) 2/21 (9.5%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Arthritis 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Joint Swelling 0/15 (0%) 0/21 (0%) 0/21 (0%) 2/18 (11.1%) 0/11 (0%) 0/23 (0%)
    Spondylitis 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Myalgia 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Pain in Extremity 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 2/23 (8.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Melanoma 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Mantle Cell Lymphoma Stage IV 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Adenocarcinoma 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Gastrointestinal Carcinoma 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Malignant Ascites 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Nervous system disorders
    Headache 2/15 (13.3%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 1/23 (4.3%)
    Visual Field Defect 1/15 (6.7%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 4/23 (17.4%)
    Dizziness 0/15 (0%) 0/21 (0%) 0/21 (0%) 2/18 (11.1%) 0/11 (0%) 0/23 (0%)
    Sciatica 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Psychiatric disorders
    Insomnia 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 2/11 (18.2%) 0/23 (0%)
    Anxiety 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Depression 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Renal and urinary disorders
    Urinary Incontinence 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Reproductive system and breast disorders
    Prostatomegaly 0/15 (0%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 1/11 (9.1%) 1/23 (4.3%)
    Upper-airway Cough Syndrome 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Allergic Sinusitis 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Hiccups 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Nasal Congestion 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Oropharyngeal Pain 0/15 (0%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 0/23 (0%)
    Pulmonary Oedema 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Skin and subcutaneous tissue disorders
    Rash 1/15 (6.7%) 0/21 (0%) 0/21 (0%) 1/18 (5.6%) 0/11 (0%) 1/23 (4.3%)
    Ingrowing Nail 0/15 (0%) 0/21 (0%) 0/21 (0%) 0/18 (0%) 1/11 (9.1%) 0/23 (0%)
    Vascular disorders
    Hypertension 1/15 (6.7%) 0/21 (0%) 1/21 (4.8%) 0/18 (0%) 0/11 (0%) 1/23 (4.3%)
    Hypotension 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)
    Phlebitis 0/15 (0%) 1/21 (4.8%) 0/21 (0%) 0/18 (0%) 0/11 (0%) 0/23 (0%)

    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 IR-CTRegistration@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01157364
    Other Study ID Numbers:
    • 192024-041D
    • 2011-005091-42
    First Posted:
    Jul 7, 2010
    Last Update Posted:
    Mar 30, 2020
    Last Verified:
    Mar 1, 2020