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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705757
• Other study ID #: Pfizer GA6111AX
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2008
• Last updated: December 14, 2015
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: December 2015
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Application Site Pigmentation Changes
• Glaucoma

Intervention

Drug:
• latanoprost
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
• bimatoprost
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
• travoprost
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	Arlington Eye Physicians	Arlington Heights	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Wand M, Ritch R, Isbey EK Jr, Zimmerman TJ. Latanoprost and periocular skin color changes. Arch Ophthalmol. 2001 Apr;119(4):614-5. — View Citation

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Wu H, Wang H, Li H, Oshuaakey J, Xiao F, Ke Y, Xu H, Xiao J, Lu D, Parra E, Shriver M, Xiong M, Barton SA, Hewett-Emmett D, Liu W, Ji L. Skin reflectance in the Han Chinese and Tibetan populations. Hum Biol. 2001 Jun;73(3):461-6. — View Citation

Youn JI, Park JY, Jo SJ, Rim JH, Choe YB. Assessment of the usefulness of skin phototype and skin color as the parameter of cutaneous narrow band UVB sensitivity in psoriasis patients. Photodermatol Photoimmunol Photomed. 2003 Oct;19(5):261-4. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No