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The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye

Sponsor
Summa Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00705757
Collaborator
(none)
89
Enrollment
2
Locations
3
Arms
37
Duration (Months)
44.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

One uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. There are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. Qualifying patients will be randomly assigned to use one of the three eye drops. We will take skin color measurements from several locations on the face over one year to measure pigmentation changes.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lumigan

Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)

Drug: bimatoprost
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
Other Names:
  • Lumigan 0.03%

    		•
    Active Comparator: Xalatan

    Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)

    Drug: latanoprost
    Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
    Other Names:
  • Xalatan 0.005%

    		•
    Active Comparator: Travatan

    Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)

    Drug: travoprost
    Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
    Other Names:
  • Travatan 0.004%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients. [one year]

      Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity. Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement.

    Eligibility Criteria

    Criteria

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

    • patients recently diagnosed with primary open angle glaucoma or ocular hypertension

    • Caucasian and African American ethnicities

    • Male and Female

    • Age 30 and above

    Exclusion Criteria:

    • A history of ocular medication use within the last 12 months

    • Inflammatory/ allergic skin diseases or dermatitis

    • presence of periocular hyperpigmented skin lesions

    • Systemic pigmentation disorders

    • Use of systemic drugs that can affect skin pigmentation

    • Visitation of tanning salons, or use of self tanning products

    • Pregnancy or patients planning to become pregnant in the near future

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arlington Eye Physicians Arlington Heights Illinois United States 60005
    2 Summa Health System Akron Ohio United States 44304

    Sponsors and Collaborators

    • Summa Health System

    Investigators

    • Principal Investigator: Deepak P Edward, MD, Summa Health System
    • Principal Investigator: Smajo Osmanovic, MD, Arlington eye Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Deepak P. Edward, PI, Summa Health System
    ClinicalTrials.gov Identifier:
    NCT00705757
    Other Study ID Numbers:
    • Pfizer GA6111AX
    First Posted:
    Jun 26, 2008
    Last Update Posted:
    Jan 18, 2016
    Last Verified:
    Dec 1, 2015
    Keywords provided by Deepak P. Edward, PI, Summa Health System
    periocular skin pigmentation
    Lumigan
    Travatan
    Xalatan
    latanoprost
    bimatoprost
    travoprost
    Additional relevant MeSH terms:
    Glaucoma
    Bimatoprost
    Travoprost
    Latanoprost

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Lumigan Xalatan Travatan
    Arm/Group Description Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
    Period Title: Overall Study
    STARTED 32 29 28
    COMPLETED 19 21 17
    NOT COMPLETED 13 8 11

    Baseline Characteristics

    Arm/Group Title Lumigan Xalatan Travatan Total
    Arm/Group Description Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) Total of all reporting groups
    Overall Participants 19 21 17 57
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    61.5
    59.2
    60.5
    60.4
    Sex: Female, Male (Count of Participants)
    Female
    10
    52.6%
    8
    38.1%
    9
    52.9%
    27
    47.4%
    Male
    9
    47.4%
    13
    61.9%
    8
    47.1%
    30
    52.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    21.1%
    2
    9.5%
    4
    23.5%
    10
    17.5%
    White
    15
    78.9%
    19
    90.5%
    13
    76.5%
    47
    82.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.
    Description Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity. Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement.
    Time Frame one year

    Outcome Measure Data

    Analysis Population Description
    Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.
    Arm/Group Title Lumigan Xalatan Travatan
    Arm/Group Description Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s). Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s). Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
    Measure Participants 19 21 17
    Upper Lid
    -0.90
    (0.67)
    -1.42
    (0.57)
    -0.90
    (0.53)
    Lower Lid
    -0.37
    (0.30)
    0.48
    (0.40)
    0.17
    (0.40)
    Cheek/Face
    0.30
    (0.29)
    0.55
    (0.33)
    0.51
    (0.41)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Lumigan, Xalatan, Travatan
    Comments One way ANOVA of Upper Lid
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.769
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Lumigan, Xalatan, Travatan
    Comments One way ANOVA of Lower Lid
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.230
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Lumigan, Xalatan, Travatan
    Comments One way ANOVA of cheek/face
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.851
    Comments
    Method ANOVA
    Comments

    Adverse Events

    Time Frame Data was collected for one year.
    Adverse Event Reporting Description
    Arm/Group Title Lumigan Xalatan Travatan
    Arm/Group Description Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
    All Cause Mortality
    Lumigan Xalatan Travatan
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Lumigan Xalatan Travatan
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/32 (0%) 0/29 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Lumigan Xalatan Travatan
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/32 (3.1%) 0/29 (0%) 0/28 (0%)
    Eye disorders
    Recurrence of iritis at 6 week visit 1/32 (3.1%) 0/29 (0%) 0/28 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Deepak P. Edward, MD
    Organization Summa Health System ( at the time of the trial)
    Phone 330-780-0399
    Email deepak.edward@gmail.com
    Responsible Party:
    Deepak P. Edward, PI, Summa Health System
    ClinicalTrials.gov Identifier:
    NCT00705757
    Other Study ID Numbers:
    • Pfizer GA6111AX
    First Posted:
    Jun 26, 2008
    Last Update Posted:
    Jan 18, 2016
    Last Verified:
    Dec 1, 2015