Clinical trial NCT00705757: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Application Site Pigmentation Changes
Keywords: periocular skin pigmentation
Lumigan
Travatan
Xalatan
latanoprost
bimatoprost
travoprost
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 89
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Arlington Eye Physicians
state: Illinois
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Summa Health System
name: Deepak P Edward, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arlington eye Associates
name: Smajo Osmanovic, MD
role: PRINCIPAL_INVESTIGATOR
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