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

December 14, 2015 updated by: Deepak P. Edward, Summa Health System

The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Arlington Eye Physicians
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summa Health System

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pfizer GA6111AX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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