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A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01470118
Collaborator
(none)
127
Enrollment
1
Location
3
Arms
2
Duration (Months)
63.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: alcaftadine 0.25% ophthalmic solution
  • Drug: olopatadine 0.2% ophthalmic solution
  • Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: LASTACAFT® (alcaftadine 0.25%)

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Drug: alcaftadine 0.25% ophthalmic solution
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Other Names:
  • LASTACAFT®

    		•
    Active Comparator: Pataday™ (olopatadine 0.2%)

    One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

    Drug: olopatadine 0.2% ophthalmic solution
    One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
    Other Names:
  • Pataday™

    		•
    Placebo Comparator: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

    One drop of placebo instilled in each eye at Day 0 and Day 14.

    Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
    One drop of placebo instilled in each eye at Day 0 and Day 14.
    Other Names:
  • Tears Naturale® II Artificial Tears

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 [Day 0 Hour 16]

      Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

    2. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

    Secondary Outcome Measures

    1. Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.

    2. Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.

    3. Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.

    4. Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.

    5. Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.

    6. Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [Day 14 Hour 24]

      Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.

    Eligibility Criteria

    Criteria

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

    • History of eye allergies within the past 24 months

    • Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

    Exclusion Criteria:

    • Current eye infection

    • Eye surgery within 3 months or vision correction surgery within 6 months

    • Any planned surgery during the study or 30 days after the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Philadelphia Pennsylvania 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:
    NCT01470118
    Other Study ID Numbers:
    • GMA-LAS-011-001
    First Posted:
    Nov 11, 2011
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Conjunctivitis
    Conjunctivitis, Allergic
    Olopatadine Hydrochloride
    Dextrans
    Pharmaceutical Solutions
    Ophthalmic Solutions
    Lubricant Eye Drops
    Alcaftadine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Period Title: Overall Study
    STARTED 43 43 41
    COMPLETED 38 38 39
    NOT COMPLETED 5 5 2

    Baseline Characteristics

    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) Total
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14. Total of all reporting groups
    Overall Participants 43 43 41 127
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    39.3
    (12.44)
    37.0
    (14.84)
    39.3
    (12.31)
    38.5
    (13.21)
    Sex: Female, Male (Count of Participants)
    Female
    31
    72.1%
    33
    76.7%
    28
    68.3%
    92
    72.4%
    Male
    12
    27.9%
    10
    23.3%
    13
    31.7%
    35
    27.6%

    Outcome Measures

    1. Primary Outcome
    Title Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
    Description Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
    Time Frame Day 0 Hour 16

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    3 Minutes
    0.62
    (0.716)
    1.01
    (0.8211)
    2.14
    (0.864)
    5 Minutes
    0.93
    (0.789)
    1.13
    (0.852)
    2.35
    (0.759)
    7 Minutes
    1.07
    (0.830)
    1.12
    (0.824)
    2.20
    (0.888)
    2. Secondary Outcome
    Title Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    1.74
    (0.612)
    1.78
    (0.709)
    2.08
    (0.605)
    15 Minutes
    2.01
    (0.672)
    2.01
    (0.805)
    2.22
    (0.671)
    20 Minutes
    1.99
    (0.652)
    1.92
    (0.870)
    2.20
    (0.691)
    3. Secondary Outcome
    Title Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    1.36
    (0.730)
    1.47
    (0.773)
    1.83
    (0.764)
    15 Minutes
    1.64
    (0.805)
    1.67
    (0.901)
    2.00
    (0.772)
    20 Minutes
    1.67
    (0.754)
    1.65
    (0.909)
    1.94
    (0.844)
    4. Secondary Outcome
    Title Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    1.65
    (0.667)
    1.56
    (0.827)
    2.01
    (0.682)
    15 Minutes
    1.95
    (0.649)
    1.82
    (0.924)
    2.15
    (0.727)
    20 Minutes
    1.91
    (0.645)
    1.79
    (0.960)
    2.13
    (0.718)
    5. Secondary Outcome
    Title Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    0.90
    (0.392)
    0.97
    (0.479)
    1.15
    (0.505)
    15 Minutes
    1.03
    (0.403)
    1.09
    (0.616)
    1.34
    (0.668)
    20 Minutes
    1.14
    (0.457)
    1.13
    (0.677)
    1.42
    (0.742)
    6. Secondary Outcome
    Title Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    0.4
    (0.62)
    0.4
    (0.51)
    1.0
    (0.75)
    15 Minutes
    0.5
    (0.66)
    0.6
    (0.74)
    1.0
    (0.88)
    20 Minutes
    0.6
    (0.65)
    0.6
    (0.77)
    1.1
    (0.87)
    7. Secondary Outcome
    Title Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
    Description Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    7 Minutes
    0.3
    (0.49)
    0.4
    (0.81)
    1.0
    (0.91)
    15 Minutes
    0.5
    (0.62)
    0.6
    (0.93)
    0.9
    (0.87)
    20 Minutes
    0.5
    (0.60)
    0.6
    (1.03)
    0.8
    (0.86)
    8. Primary Outcome
    Title Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
    Description Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
    Time Frame Day 14 Hour 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat: All randomized subjects
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    Measure Participants 43 43 41
    3 Minutes
    0.64
    (0.807)
    0.97
    (0.771)
    2.27
    (0.846)
    5 Minutes
    0.84
    (0.851)
    1.16
    (0.886)
    2.19
    (0.897)
    7 Minutes
    0.93
    (0.911)
    1.01
    (0.932)
    1.96
    (1.068)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The Safety Population was defined as all randomized subjects who received at least one dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).
    Arm/Group Title LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Arm/Group Description One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. One drop of placebo instilled in each eye at Day 0 and Day 14.
    All Cause Mortality
    LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/42 (0%) 0/41 (0%)
    Other (Not Including Serious) Adverse Events
    LASTACAFT® (Alcaftadine 0.25%) Pataday™ (Olopatadine 0.2%) Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/42 (0%) 0/41 (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 Vice President Medical Affairs,
    Organization Allergan, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01470118
    Other Study ID Numbers:
    • GMA-LAS-011-001
    First Posted:
    Nov 11, 2011
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Jan 1, 2013