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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Summa Health System.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
DEdward, Summa Health System Identifier:
First received: June 24, 2008
Last updated: December 14, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Periocular Skin Pigmentation Changes
Drug: Latanoprost
Drug: Bimatoprost
Drug: Travoprost
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation

Resource links provided by NLM:

Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • skin pigmentation changes [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients assigned to Lumigan
Drug: Bimatoprost
0.03% Bimatoprost ophthalmic sol. one drop qhs for one year
Other Name: Lumigan
Active Comparator: 2
Patients assigned to Xalatan
Drug: Latanoprost
0.005% ophthalmic sol. one drop qhs for one year
Other Name: Xalatan
Active Comparator: 3
Patients assigned to Travatan
Drug: Travoprost
0.004% ophthalmic sol., one drop qhs for one year
Other Name: Travatan

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.

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00705757

United States, Illinois
Arlington Eye Physicians
Arlington Heights, Illinois, United States, 60005
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Principal Investigator: Deepak P Edward, MD Summa Health System
Principal Investigator: Smajo Osmanovic, MD Arlington eye Associates
  More Information

Lee JA, Osmanovic S, Viana MAG, Kapur R, Meghpara B, Edward DP.Objective measurement of Periocular Pigmentation. Invest. Ophthalmol. Vis Sci. 2006 47: E-Abstract 462

Responsible Party: DEdward, PI, Summa Health System Identifier: NCT00705757     History of Changes
Other Study ID Numbers: Pfizer GA6111AX
Study First Received: June 24, 2008
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
periocular skin pigmentation

Additional relevant MeSH terms:
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015