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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DEdward, Summa Health System
ClinicalTrials.gov Identifier:
NCT00705757
First received: June 24, 2008
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Glaucoma
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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705757

Locations
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
Investigators
Principal Investigator: Deepak P Edward, MD Summa Health System
Principal Investigator: Smajo Osmanovic, MD Arlington eye Associates
  More Information

Publications:
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
ClinicalTrials.gov 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
Lumigan
travatan
Xalatan
 latanoprost
bimatoprost
travoprost

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Travoprost
 Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013