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Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01027650
Collaborator
(none)
121
Enrollment
5
Locations
8
Arms
35.1
Duration (Months)
24.2
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.

Condition or Disease Intervention/Treatment Phase
  • Drug: AGN208397 intravitreal injection
  • Drug: dexamethasone intravitreal implant
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stage 1 Cohort 1

AGN208397 intravitreal injection 75 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 2

AGN208397 intravitreal injection 300 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 3

AGN208397 intravitreal injection 600 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 4

AGN208397 intravitreal injection 900 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 1

AGN208397 intravitreal injection 600 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 2

AGN208397 intravitreal injection 450 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 3

AGN208397 intravitreal injection 300 ug on Day 1.

Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Active Comparator: Stage 2 Arm 4

Dexamethasone 700 ug intravitreal implant on Day 1.

Drug: dexamethasone intravitreal implant
Dexamethasone 700 ug intravitreal implant on Day 1.
Other Names:
  • Ozurdex®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 [Baseline, Month 1]

      Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

    2. Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 [Baseline, Month 1]

      Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

    3. Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 [Baseline, Month 1]

      BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    4. Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 [Baseline, Month 1]

      BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    Secondary Outcome Measures

    1. Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 [Baseline, Month 12]

      Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

    2. Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 [Baseline, Month 12]

      Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.

    3. Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 [Baseline, Month 12]

      BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    4. Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 [Baseline, Month 12]

      BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • macular edema due to retinal vein occlusion

    • visual acuity in the study eye between 20/320 to 20/40

    Exclusion Criteria:

    • cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)

    • use of injectable drugs in the study eye within 2 months prior to day 1

    • active eye infection in either eye

    • visual acuity in the non-study eye of 20/200 or worse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States
    2 East Melbourne Victoria Australia
    3 London Ontario Canada
    4 Tel Aviv Israel
    5 Cape Town South Africa

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01027650
    Other Study ID Numbers:
    • 208397-001
    First Posted:
    Dec 8, 2009
    Last Update Posted:
    Apr 29, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Vein Occlusion
    Edema
    Dexamethasone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Doses for Stage 2 were selected based on the safety and pharmacodynamic results from Stage 1. No patients in Stage 1 were enrolled in Stage 2.
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    Period Title: Overall Study
    STARTED 6 6 6 3 25 26 25 24
    COMPLETED 6 6 6 3 23 24 24 24
    NOT COMPLETED 0 0 0 0 2 2 1 0

    Baseline Characteristics

    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4 Total
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1. Total of all reporting groups
    Overall Participants 6 6 6 3 25 26 25 24 121
    Age, Customized (Number) [Number]
    <45 years
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    11.5%
    3
    12%
    3
    12.5%
    10
    8.3%
    Between 45 and 65 years
    3
    50%
    4
    66.7%
    4
    66.7%
    0
    0%
    8
    32%
    10
    38.5%
    11
    44%
    9
    37.5%
    49
    40.5%
    >65 years
    2
    33.3%
    2
    33.3%
    2
    33.3%
    3
    100%
    17
    68%
    13
    50%
    11
    44%
    12
    50%
    62
    51.2%
    Sex: Female, Male (Count of Participants)
    Female
    2
    33.3%
    2
    33.3%
    3
    50%
    1
    33.3%
    10
    40%
    11
    42.3%
    13
    52%
    12
    50%
    54
    44.6%
    Male
    4
    66.7%
    4
    66.7%
    3
    50%
    2
    66.7%
    15
    60%
    15
    57.7%
    12
    48%
    12
    50%
    67
    55.4%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
    Description Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
    Time Frame Baseline, Month 1

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all patients who received study treatment
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1.
    Measure Participants 6 6 6 3
    Baseline
    500.2
    (197.58)
    495.8
    (163.13)
    499.5
    (158.33)
    468.3
    (24.34)
    Change from Baseline at Month 1
    -234.3
    (200.23)
    -210.5
    (173.69)
    -256.2
    (102.61)
    -206.7
    (96.40)
    2. Primary Outcome
    Title Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
    Description Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
    Time Frame Baseline, Month 1

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
    Arm/Group Title Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    Measure Participants 23 25 21 23
    Baseline
    612.6
    (166.15)
    637.8
    (203.69)
    597.9
    (217.54)
    679.7
    (237.20)
    Change from Baseline at Month 1
    -298.5
    (174.59)
    -314.1
    (169.35)
    -307.0
    (217.98)
    -317.3
    (212.51)
    3. Primary Outcome
    Title Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
    Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
    Time Frame Baseline, Month 1

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all patients who received study treatment
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1.
    Measure Participants 6 6 6 3
    Baseline
    54.5
    (16.13)
    50.2
    (14.12)
    59.7
    (6.62)
    53.0
    (9.54)
    Change from Baseline at Month 1
    10.0
    (8.72)
    11.7
    (7.17)
    8.7
    (4.84)
    9.7
    (2.31)
    4. Primary Outcome
    Title Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
    Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
    Time Frame Baseline, Month 1

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
    Arm/Group Title Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    Measure Participants 23 25 22 23
    Baseline
    49.5
    (12.88)
    47.6
    (13.60)
    58.2
    (12.89)
    50.5
    (14.27)
    Change from Baseline at Month 1
    12.0
    (9.38)
    12.5
    (12.74)
    14.0
    (12.35)
    11.0
    (11.99)
    5. Secondary Outcome
    Title Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
    Description Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all patients who received study treatment
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1.
    Measure Participants 6 6 6 3
    Baseline
    500.2
    (197.58)
    495.8
    (163.13)
    499.5
    (158.33)
    468.3
    (24.34)
    Change from Baseline at Month 12 (N=3, 3, 3, 3)
    -221.7
    (208.33)
    -173.0
    (145.01)
    -239.7
    (121.33)
    -167.7
    (96.72)
    6. Secondary Outcome
    Title Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
    Description Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
    Arm/Group Title Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    Measure Participants 23 25 21 23
    Baseline
    612.6
    (166.15)
    637.8
    (203.69)
    597.9
    (217.54)
    679.7
    (237.20)
    Change from Baseline at Month 12
    -252.8
    (177.09)
    -218.0
    (166.57)
    -208.2
    (200.48)
    -169.1
    (213.50)
    7. Secondary Outcome
    Title Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
    Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all patients who received study treatment
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1.
    Measure Participants 6 6 6 3
    Baseline
    54.5
    (16.13)
    50.2
    (14.12)
    59.7
    (6.62)
    53.0
    (9.54)
    Change from Baseline at Month 12 (N=6, 5, 6, 3)
    14.2
    (15.30)
    0.8
    (24.88)
    11.0
    (7.43)
    14.0
    (5.29)
    8. Secondary Outcome
    Title Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
    Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
    Arm/Group Title Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    Measure Participants 23 25 22 23
    Baseline
    49.5
    (12.88)
    47.6
    (13.60)
    58.2
    (12.89)
    50.5
    (14.27)
    Change from Baseline at Month 12
    8.0
    (13.55)
    10.2
    (17.22)
    12.4
    (14.31)
    5.0
    (11.18)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Adverse events (AEs) and serious adverse events (SAEs) are reported by treatment group assigned during Stage 1 and Stage 2. The Safety Population consisted of all patients who received the study treatment, and was used to assess AEs and SAEs.
    Arm/Group Title Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Arm/Group Description AGN208397 intravitreal injection 900 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. AGN208397 intravitreal injection 75 ug on Day 1. AGN208397 intravitreal injection 600 ug on Day 1. AGN208397 intravitreal injection 450 ug on Day 1. AGN208397 intravitreal injection 300 ug on Day 1. Dexamethasone 700 ug intravitreal implant on Day 1.
    All Cause Mortality
    Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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) / (NaN) / (NaN)
    Serious Adverse Events
    Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 4/25 (16%) 4/26 (15.4%) 2/25 (8%) 3/24 (12.5%)
    Cardiac disorders
    Cardiac Failure Congestive 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Atrioventricular Block Second Degree 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 1/25 (4%) 0/24 (0%)
    Myocardial Ischaemia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Eye disorders
    Pseudoendophthalmitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Gastrointestinal disorders
    Gastric Ulcer 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    General disorders
    Chest Pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 1/25 (4%) 0/24 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Infections and infestations
    Pneumonia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Injury, poisoning and procedural complications
    Ankle Fracture 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Musculoskeletal and connective tissue disorders
    Exostosis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Facet Joint Syndrome 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Pain in Extremity 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Rhabdomyolysis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Basal Cell Carcinoma 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia 0/4 (0%) 0/4 (0%) 0/3 (0%) 0/2 (0%) 0/15 (0%) 1/15 (6.7%) 0/12 (0%) 0/12 (0%)
    Vascular disorders
    Vasculitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Other (Not Including Serious) Adverse Events
    Stage 1 Cohort 4 Stage 1 Cohort 3 Stage 1 Cohort 2 Stage 1 Cohort 1 Stage 2 Arm 1 Stage 2 Arm 2 Stage 2 Arm 3 Stage 2 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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 6/6 (100%) 6/6 (100%) 6/6 (100%) 3/3 (100%) 25/25 (100%) 26/26 (100%) 25/25 (100%) 24/24 (100%)
    Blood and lymphatic system disorders
    Anaemia 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Cardiac disorders
    Atrial Fibrillation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Angina Pectoris 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 2/24 (8.3%)
    Ear and labyrinth disorders
    Vertigo 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Eye disorders
    Conjunctival Haemorrhage 2/6 (33.3%) 3/6 (50%) 2/6 (33.3%) 1/3 (33.3%) 6/25 (24%) 6/26 (23.1%) 4/25 (16%) 9/24 (37.5%)
    Cataract 2/6 (33.3%) 2/6 (33.3%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 4/26 (15.4%) 1/25 (4%) 1/24 (4.2%)
    Retinal Haemorrhage 2/6 (33.3%) 1/6 (16.7%) 4/6 (66.7%) 2/3 (66.7%) 4/25 (16%) 7/26 (26.9%) 6/25 (24%) 3/24 (12.5%)
    Eye Pain 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 1/25 (4%) 3/24 (12.5%)
    Macular Fibrosis 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Ocular Hypertension 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 3/26 (11.5%) 1/25 (4%) 1/24 (4.2%)
    Cystoid Macular Oedema 1/6 (16.7%) 0/6 (0%) 3/6 (50%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 3/25 (12%) 3/24 (12.5%)
    Eye Pruritus 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Vitreous Floaters 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 4/25 (16%) 7/26 (26.9%) 3/25 (12%) 0/24 (0%)
    Arteriosclerotic Retinopathy 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Blepharitis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 2/26 (7.7%) 1/25 (4%) 0/24 (0%)
    Eye Swelling 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Visual Acuity Reduced 0/6 (0%) 3/6 (50%) 1/6 (16.7%) 0/3 (0%) 3/25 (12%) 5/26 (19.2%) 0/25 (0%) 3/24 (12.5%)
    Vitreous Detachment 0/6 (0%) 2/6 (33.3%) 1/6 (16.7%) 1/3 (33.3%) 2/25 (8%) 0/26 (0%) 1/25 (4%) 5/24 (20.8%)
    Cataract subcapsular 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 2/26 (7.7%) 3/25 (12%) 2/24 (8.3%)
    Foreign Body Sensation in Eyes 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Macular Oedema 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 3/25 (12%) 5/26 (19.2%) 5/25 (20%) 11/24 (45.8%)
    Photophobia 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Conjunctival Hyperaemia 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Conjunctival Oedema 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Glaucoma 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 2/26 (7.7%) 0/25 (0%) 0/24 (0%)
    Iris Adhesions 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Iris Neovascularisation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Optic Nerve Infarction 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Posterior Capsule Opacification 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Retinal Aneurysm 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 1/25 (4%) 0/24 (0%)
    Retinal Neovascularisation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Vitreous Opacities 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 2/26 (7.7%) 0/25 (0%) 0/24 (0%)
    Vision Blurred 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 1/3 (33.3%) 3/25 (12%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Diabetic Retinopathy 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Dry Eye 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 1/25 (4%) 1/24 (4.2%)
    Macular Cyst 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Macular Degeneration 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 2/24 (8.3%)
    Retinal Exudates 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 4/25 (16%) 3/26 (11.5%) 4/25 (16%) 3/24 (12.5%)
    Cataract Nuclear 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 1/25 (4%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Pterygium 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 0/25 (0%) 0/26 (0%) 1/25 (4%) 0/24 (0%)
    Retinal pigment epitheliopathy 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 2/25 (8%) 0/26 (0%) 0/25 (0%) 2/24 (8.3%)
    Retinal Vein Occlusion 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 2/25 (8%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Conjunctivitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 2/26 (7.7%) 0/25 (0%) 2/24 (8.3%)
    Optic Disc Haemorrhage 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 2/24 (8.3%)
    Anterior Chamber Cell 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Anterior Chamber Angle Neovascularisation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Anterior Chamber Flare 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Anterior Chamber Inflammation 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Lenticular Opacities 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 1/25 (4%) 0/24 (0%)
    Gastrointestinal disorders
    Abdominal Pain Upper 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Gastritis 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Nausea 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 1/24 (4.2%)
    Vomiting 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Constipation 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 2/25 (8%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Gastrooesophageal Reflux Disease 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 2/26 (7.7%) 0/25 (0%) 0/24 (0%)
    General disorders
    Medication Residue 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Oedema Peripheral 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Pyrexia 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Facial Pain 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Malaise 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Immune system disorders
    Hypersensitivity 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Seasonal Allergy 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 1/25 (4%) 0/24 (0%)
    Infections and infestations
    Upper Respiratory Tract Infection 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 1/24 (4.2%)
    Cystitis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Pneumonia 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 2/25 (8%) 1/24 (4.2%)
    Upper Respiratory Tract Infection Bacterial 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Urinary Tract Infection 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/3 (33.3%) 1/25 (4%) 0/26 (0%) 1/25 (4%) 2/24 (8.3%)
    Nasopharyngitis 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 3/26 (11.5%) 2/25 (8%) 1/24 (4.2%)
    Localised Infection 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Sinusitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 2/25 (8%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Influenza 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 2/25 (8%) 0/24 (0%)
    Bronchitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 2/25 (8%) 1/24 (4.2%)
    Vulvovaginal Mycotic Infection 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/1 (0%) 0/10 (0%) 0/11 (0%) 1/13 (7.7%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Laceration 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Fall 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 2/25 (8%) 2/26 (7.7%) 1/25 (4%) 0/24 (0%)
    Excoriation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Animal bite 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Investigations
    Intraocular Pressure Increased 4/6 (66.7%) 3/6 (50%) 1/6 (16.7%) 0/3 (0%) 6/25 (24%) 8/26 (30.8%) 9/25 (36%) 5/24 (20.8%)
    Blood Urea Increased 2/6 (33.3%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Blood Glucose Increased 1/6 (16.7%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 0/25 (0%) 1/24 (4.2%)
    Protein Urine Present 1/6 (16.7%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Mean Cell Haemoglobin Concentration Decreased 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    White Blood Cells Urine Positive 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 1/24 (4.2%)
    Alanine Aminotransferase Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 3/25 (12%) 1/24 (4.2%)
    Aspartate Aminotransferase Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 2/25 (8%) 1/24 (4.2%)
    Blood Bilirubin Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Blood Pressure Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Gamma-Glutamyltransferase Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 2/25 (8%) 1/24 (4.2%)
    Weight Increased 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Blood Triglycerides Increased 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Nitrite Urine Present 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Urine Leukocyte Esterase Positive 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Blood Cholesterol Increased 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 2/25 (8%) 0/24 (0%)
    Metabolism and nutrition disorders
    Polydipsia 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Pain 0/6 (0%) 2/6 (33.3%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Arthralgia 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 1/26 (3.8%) 0/25 (0%) 0/24 (0%)
    Neck Pain 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Pain in Extremity 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 0/25 (0%) 3/26 (11.5%) 0/25 (0%) 0/24 (0%)
    Exostosis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 2/26 (7.7%) 0/25 (0%) 0/24 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Eye Naevus 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Basal Cell Carcinoma 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Blepharal Papilloma 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/3 (33.3%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Nervous system disorders
    Headache 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 1/26 (3.8%) 3/25 (12%) 1/24 (4.2%)
    Syncope 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Psychiatric disorders
    Suicidal Ideation 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Reproductive system and breast disorders
    Vulvovaginal Pruritus 1/2 (50%) 0/2 (0%) 0/3 (0%) 0/1 (0%) 0/10 (0%) 0/11 (0%) 0/13 (0%) 0/12 (0%)
    Benign Prostatic Hyperplasia 0/4 (0%) 0/4 (0%) 0/3 (0%) 1/2 (50%) 0/15 (0%) 1/15 (6.7%) 0/12 (0%) 1/12 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Tract Congestion 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Cough 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/3 (0%) 1/25 (4%) 3/26 (11.5%) 0/25 (0%) 1/24 (4.2%)
    Dyspnoea 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 1/24 (4.2%)
    Skin and subcutaneous tissue disorders
    Dermatitis Contact 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 0/26 (0%) 0/25 (0%) 0/24 (0%)
    Vascular disorders
    Hypertension 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/3 (0%) 0/25 (0%) 2/26 (7.7%) 0/25 (0%) 4/24 (16.7%)

    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, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01027650
    Other Study ID Numbers:
    • 208397-001
    First Posted:
    Dec 8, 2009
    Last Update Posted:
    Apr 29, 2014
    Last Verified:
    Mar 1, 2014