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Completed

NCT Number: NCT00705757

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

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.

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Key information

Conditions

Glaucoma Application Site Pigmentation Changes Eye Diseases Ocular Hypertension

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arlington Eye Physicians, Arlington Heights, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

latanoprost

Drug

Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year

Other names: Xalatan 0.005%

Bimatoprost

Drug

Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year

Other names: Lumigan 0.03%

Travoprost

Drug

Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year

Other names: Travatan 0.004%

Primary outcomes

  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.

    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.

Sponsors and collaborators

Lead sponsor

Summa Health System

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 26, 2008
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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