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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Application Site Pigmentation Changes

Intervention / Treatment
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* Drug: latanoprost
* Drug: bimatoprost
* Drug: travoprost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumigan<br>Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s) | Drug: bimatoprost<br>* Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year<br>* Other names: Lumigan 0.03%;|
| Active Comparator: Xalatan<br>Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s) | Drug: latanoprost<br>* Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year<br>* Other names: Xalatan 0.005%;|
| Active Comparator: Travatan<br>Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s) | Drug: travoprost<br>* Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year<br>* Other names: Travatan 0.004%;|

What is the study measuring?
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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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bimatoprost, periocular skin pigmentation, Lumigan, Travatan, Xalatan, latanoprost, travoprost