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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01110499
Collaborator
(none)
163
Enrollment
1
Location
8
Arms
12
Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Condition or Disease Intervention/Treatment Phase
  • Drug: AGN-210961 Formulation 1
  • Drug: AGN-210961 Formulation 2
  • Drug: AGN-210961 Formulation 3
  • Drug: AGN-210961 Formulation 4
  • Drug: AGN-210961 Formulation 5
  • Drug: AGN-210961 Formulation 6
  • Drug: AGN-210961 Formulation 7
  • Drug: bimatoprost ophthalmic solution 0.03%
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1, AGN-210961 Formulation 1

AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 2

AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 3

AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 4

AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 5

AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 6

AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Drug: AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
Experimental: Part 2, AGN-210961 Formulation 7

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Drug: AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Active Comparator: Part 2, bimatoprost ophthalmic solution 0.03%

bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Drug: bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
Other Names:
  • LUMIGAN®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Change From Baseline in Intraocular Pressure (IOP) [Baseline, Day 7]

      IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

    2. Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) [Baseline, Day 29]

      IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ocular hypertension or primary open-angle glaucoma in each eye
    Exclusion Criteria:

    • Any active ocular disease

    • Anticipated wearing of contact lenses during study

    • Anticipated use of artificial tears during study

    • Contraindication to pupil dilatation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Newport Beach California United States

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01110499
    Other Study ID Numbers:
    • 210961-002
    First Posted:
    Apr 26, 2010
    Last Update Posted:
    Aug 5, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension
    Bimatoprost
    Ophthalmic Solutions

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This was a 2-part study. Patients were enrolled in and completed Part 1 of the study. Then, based on a review of the data from Part 1, a different formulation was selected for Part 2 (Formulation 7). New patients were then enrolled in Part 2 of the study. No patients from Part 1 were enrolled in Part 2 of the study.
    Arm/Group Title Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 0.03%
    Arm/Group Description AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
    Period Title: Overall Study
    STARTED 14 14 14 14 14 14 39 40
    COMPLETED 14 14 14 14 14 14 39 40
    NOT COMPLETED 0 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 0.03% Total
    Arm/Group Description AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. Total of all reporting groups
    Overall Participants 14 14 14 14 14 14 39 40 163
    Age, Customized (Number) [Number]
    <45 years
    0
    0%
    1
    7.1%
    1
    7.1%
    1
    7.1%
    0
    0%
    0
    0%
    0
    0%
    1
    2.5%
    4
    2.5%
    45 to 65 years
    11
    78.6%
    3
    21.4%
    6
    42.9%
    8
    57.1%
    6
    42.9%
    7
    50%
    18
    46.2%
    23
    57.5%
    82
    50.3%
    >65 years
    3
    21.4%
    10
    71.4%
    7
    50%
    5
    35.7%
    8
    57.1%
    7
    50%
    21
    53.8%
    16
    40%
    77
    47.2%
    Sex: Female, Male (Count of Participants)
    Female
    12
    85.7%
    9
    64.3%
    10
    71.4%
    9
    64.3%
    7
    50%
    7
    50%
    24
    61.5%
    27
    67.5%
    105
    64.4%
    Male
    2
    14.3%
    5
    35.7%
    4
    28.6%
    5
    35.7%
    7
    50%
    7
    50%
    15
    38.5%
    13
    32.5%
    58
    35.6%

    Outcome Measures

    1. Primary Outcome
    Title Part 1: Change From Baseline in Intraocular Pressure (IOP)
    Description IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
    Time Frame Baseline, Day 7

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all treated patients
    Arm/Group Title Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 1, Bimatoprost Ophthalmic Solution 0.03%
    Arm/Group Description AGN-210961 Formulation 1 in one eye once daily for 7 days. AGN-210961 Formulation 2 in one eye once daily for 7 days. AGN-210961 Formulation 3 in one eye once daily for 7 days. AGN-210961 Formulation 4 in one eye once daily for 7 days. AGN-210961 Formulation 5 in one eye once daily for 7 days. AGN-210961 Formulation 6 in one eye once daily for 7 days. bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
    Measure Participants 14 14 14 14 14 14 84
    Measure Eyes 14 14 14 14 14 14 84
    Baseline - Hour 0
    25.4
    (2.5)
    25.6
    (2.71)
    24.3
    (1.94)
    26.7
    (3.60)
    24.4
    (1.54)
    25.3
    (2.23)
    25.3
    (2.82)
    Baseline - Hour 2
    23.1
    (2.18)
    23.5
    (2.53)
    23.6
    (2.64)
    23.6
    (3.27)
    23.1
    (3.49)
    24.1
    (3.25)
    23.4
    (2.83)
    Baseline - Hour 4
    23.5
    (2.53)
    23.1
    (2.55)
    23.6
    (3.64)
    23.0
    (3.72)
    23.1
    (2.46)
    23.7
    (2.49)
    23.2
    (2.76)
    Baseline - Hour 6
    22.0
    (2.53)
    22.0
    (2.46)
    24.4
    (4.43)
    21.9
    (3.88)
    22.1
    (2.60)
    22.4
    (2.72)
    22.5
    (3.33)
    Baseline - Hour 8
    21.6
    (2.84)
    21.3
    (2.58)
    23.2
    (3.87)
    22.1
    (4.04)
    22.2
    (2.83)
    22.9
    (2.95)
    22.3
    (3.18)
    Baseline - Hour 12
    22.1
    (2.98)
    21.6
    (3.03)
    21.8
    (3.86)
    21.6
    (4.24)
    21.3
    (1.98)
    20.8
    (2.44)
    21.5
    (3.10)
    Change from Baseline at Day 7- Hour 0
    -6.1
    (4.22)
    -6.3
    (4.24)
    -5.9
    (4.36)
    -6.0
    (3.87)
    -5.2
    (3.79)
    -5.6
    (3.16)
    -6.3
    (3.66)
    Change from Baseline at Day 7- Hour 2
    -5.3
    (3.00)
    -6.6
    (2.88)
    -6.0
    (2.72)
    -5.6
    (2.80)
    -5.3
    (3.97)
    -5.2
    (3.71)
    -5.0
    (3.06)
    Change from Baseline at Day 7- Hour 4
    -6.6
    (4.27)
    -4.5
    (2.45)
    -6.3
    (4.35)
    -4.0
    (2.48)
    -5.2
    (3.60)
    -5.2
    (3.68)
    -5.1
    (2.79)
    Change from Baseline at Day 7 - Hour 6
    -5.6
    (2.23)
    -4.5
    (3.03)
    -6.7
    (4.05)
    -3.2
    (3.49)
    -5.1
    (2.23)
    -4.7
    (2.63)
    -5.5
    (2.92)
    Change from Baseline at Day 7- Hour 8
    -5.9
    (2.91)
    -4.8
    (2.45)
    -5.8
    (3.31)
    -4.4
    (2.49)
    -5.5
    (3.28)
    -4.9
    (3.94)
    -6.2
    (2.99)
    Change from Baseline at Day 7- Hour 12
    -5.4
    (3.77)
    -4.9
    (3.39)
    -4.8
    (3.69)
    -4.8
    (3.41)
    -3.7
    (3.88)
    -3.7
    (3.21)
    -5.6
    (2.73)
    2. Primary Outcome
    Title Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
    Description IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
    Time Frame Baseline, Day 29

    Outcome Measure Data

    Analysis Population Description
    Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment
    Arm/Group Title Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 0.03%
    Arm/Group Description AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
    Measure Participants 39 40
    Baseline - Hour 0
    24.63
    (2.526)
    24.62
    (2.465)
    Baseline - Hour 2
    23.40
    (2.072)
    23.70
    (3.182)
    Baseline - Hour 4
    22.25
    (2.449)
    22.51
    (3.507)
    Baseline - Hour 6
    21.97
    (2.264)
    22.38
    (3.492)
    Baseline - Hour 8
    21.28
    (2.896)
    21.48
    (3.354)
    Baseline - Hour 12
    20.72
    (3.162)
    20.94
    (3.549)
    Change from Baseline at Day 29 - Hour 0
    -7.44
    (3.173)
    -8.63
    (3.399)
    Change from Baseline at Day 29 - Hour 2
    -7.40
    (3.269)
    -8.51
    (3.752)
    Change from Baseline at Day 29 - Hour 4
    -6.25
    (3.521)
    -7.39
    (3.993)
    Change from Baseline at Day 29 - Hour 6
    -6.31
    (3.625)
    -6.92
    (3.808)
    Change from Baseline at Day 29 - Hour 8
    -6.15
    (3.856)
    -6.31
    (4.056)
    Change from Baseline at Day 29 - Hour 12
    -5.74
    (4.086)
    -5.10
    (4.054)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
    Arm/Group Title Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 0.03%
    Arm/Group Description AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined). AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
    All Cause Mortality
    Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 1/39 (2.6%) 1/40 (2.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lip and/or Oral Cavity Cancer 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 0/39 (0%) 1/40 (2.5%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 1/39 (2.6%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Part 1, AGN-210961 Formulation 1 Part 1, AGN-210961 Formulation 2 Part 1, AGN-210961 Formulation 3 Part 1, AGN-210961 Formulation 4 Part 1, AGN-210961 Formulation 5 Part 1, AGN-210961 Formulation 6 Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye Part 2, AGN-210961 Formulation 7 Part 2, Bimatoprost Ophthalmic Solution 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/14 (71.4%) 9/14 (64.3%) 10/14 (71.4%) 6/14 (42.9%) 7/14 (50%) 5/14 (35.7%) 53/84 (63.1%) 29/39 (74.4%) 19/40 (47.5%)
    Cardiac disorders
    Bundle Branch Block Right 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 0/39 (0%) 0/40 (0%)
    Eye disorders
    Conjunctival Hyperaemia 5/14 (35.7%) 5/14 (35.7%) 6/14 (42.9%) 3/14 (21.4%) 3/14 (21.4%) 3/14 (21.4%) 42/84 (50%) 16/39 (41%) 16/40 (40%)
    Punctate Keratitis 4/14 (28.6%) 3/14 (21.4%) 5/14 (35.7%) 2/14 (14.3%) 2/14 (14.3%) 0/14 (0%) 16/84 (19%) 7/39 (17.9%) 5/40 (12.5%)
    Corneal thickening 2/14 (14.3%) 3/14 (21.4%) 3/14 (21.4%) 1/14 (7.1%) 2/14 (14.3%) 2/14 (14.3%) 0/84 (0%) 22/39 (56.4%) 1/40 (2.5%)
    Photophobia 2/14 (14.3%) 1/14 (7.1%) 2/14 (14.3%) 1/14 (7.1%) 2/14 (14.3%) 0/14 (0%) 4/84 (4.8%) 11/39 (28.2%) 0/40 (0%)
    Vision Blurred 0/14 (0%) 2/14 (14.3%) 2/14 (14.3%) 0/14 (0%) 2/14 (14.3%) 1/14 (7.1%) 2/84 (2.4%) 7/39 (17.9%) 1/40 (2.5%)
    Eye Pain 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 4/84 (4.8%) 5/39 (12.8%) 3/40 (7.5%)
    Iritis 0/14 (0%) 1/14 (7.1%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 1/39 (2.6%) 0/40 (0%)
    Lacrimation Increased 0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 2/84 (2.4%) 3/39 (7.7%) 1/40 (2.5%)
    Eye Pruritus 0/14 (0%) 0/14 (0%) 3/14 (21.4%) 1/14 (7.1%) 1/14 (7.1%) 0/14 (0%) 5/84 (6%) 2/39 (5.1%) 5/40 (12.5%)
    Eye Irritation 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 1/84 (1.2%) 1/39 (2.6%) 3/40 (7.5%)
    Foreign Body Sensation in Eyes 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/84 (0%) 2/39 (5.1%) 4/40 (10%)
    Eye Discharge 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 2/39 (5.1%) 1/40 (2.5%)
    Visual Acuity Reduced 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 2/39 (5.1%) 0/40 (0%)
    Infections and infestations
    Upper Respiratory Infection 0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 0/39 (0%) 0/40 (0%)
    Metabolism and nutrition disorders
    Hypercholesterolaemia 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 0/39 (0%) 0/40 (0%)
    Nervous system disorders
    Headache 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/84 (0%) 0/39 (0%) 0/40 (0%)
    Hemicephalalgia 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 0/14 (0%) 1/14 (7.1%) 0/84 (0%) 0/39 (0%) 0/40 (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, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01110499
    Other Study ID Numbers:
    • 210961-002
    First Posted:
    Apr 26, 2010
    Last Update Posted:
    Aug 5, 2014
    Last Verified:
    Jul 1, 2014