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

Phase 4

Completed

• Conditions: Application Site Pigmentation Changes; Glaucoma
• Interventions: Drug: bimatoprost; Drug: latanoprost; Drug: travoprost

• Registration Number: NCT00705757
• Lead Sponsor: Summa Health System

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2014-12-25
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Results First Posted: 2016-01-18
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumigan	bimatoprost	Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
Xalatan	latanoprost	Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
Travatan	travoprost	Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Arlington Eye Physicians; 🇺🇸 Arlington Heights, Illinois, United States

Summa Health System; 🇺🇸 Akron, Ohio, United States