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

Primary Purpose

Glaucoma, Application Site Pigmentation Changes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
latanoprost
bimatoprost
travoprost
Sponsored by
Summa Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, bimatoprost, travoprost

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arlington Eye Physicians
  • Summa Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lumigan

Xalatan

Travatan

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2008
Last Updated
December 14, 2015
Sponsor
Summa Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00705757
Brief Title
The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
Official Title
The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Summa Health System

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Application Site Pigmentation Changes
Keywords
periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, bimatoprost, travoprost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumigan
Arm Type
Active Comparator
Arm Description
Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
Arm Title
Xalatan
Arm Type
Active Comparator
Arm Description
Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
Arm Title
Travatan
Arm Type
Active Comparator
Arm Description
Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
Intervention Type
Drug
Intervention Name(s)
latanoprost
Other Intervention Name(s)
Xalatan 0.005%
Intervention Description
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
Intervention Type
Drug
Intervention Name(s)
bimatoprost
Other Intervention Name(s)
Lumigan 0.03%
Intervention Description
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
Intervention Type
Drug
Intervention Name(s)
travoprost
Other Intervention Name(s)
Travatan 0.004%
Intervention Description
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak P Edward, MD
Organizational Affiliation
Summa Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Smajo Osmanovic, MD
Organizational Affiliation
Arlington eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arlington Eye Physicians
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States

12. IPD Sharing Statement

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

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