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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deepak P. Edward, Summa Health System
ClinicalTrials.gov Identifier:
NCT00705757
First received: June 24, 2008
Last updated: December 14, 2015
Last verified: December 2015
  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
Application Site 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:
  • 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. [ Time Frame: one year ] [ Designated as safety issue: No ]

    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.



Enrollment: 89
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lumigan
Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
Drug: bimatoprost
Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
Other Name: Lumigan 0.03%
Active Comparator: Xalatan
Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
Drug: latanoprost
Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
Other Name: Xalatan 0.005%
Active Comparator: Travatan
Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
Drug: travoprost
Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
Other Name: Travatan 0.004%

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   (Adult, Senior)
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
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 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: Deepak P. Edward, PI, Summa Health System
ClinicalTrials.gov Identifier: NCT00705757     History of Changes
Other Study ID Numbers: Pfizer GA6111AX 
Study First Received: June 24, 2008
Results First Received: December 25, 2014
Last Updated: December 14, 2015
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
Ophthalmic Solutions
Latanoprost
Bimatoprost
Travoprost
Pharmaceutical Solutions
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 22, 2016