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

June 24, 2008
December 14, 2015
March 2008
April 2011   (final data collection date for primary outcome 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. [ 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.

skin pigmentation changes [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00705757 on ClinicalTrials.gov Archive Site
Not Provided
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The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma
  • Application Site Pigmentation Changes
  • Drug: latanoprost
    Xalatan/latanoprost 0.005% ophthalmic solution one drop qhs for one year
    Other Name: Xalatan 0.005%
  • Drug: bimatoprost
    Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year
    Other Name: Lumigan 0.03%
  • Drug: travoprost
    Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year
    Other Name: Travatan 0.004%
  • Active Comparator: Lumigan
    Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)
    Intervention: Drug: bimatoprost
  • Active Comparator: Xalatan
    Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)
    Intervention: Drug: latanoprost
  • Active Comparator: Travatan
    Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)
    Intervention: Drug: travoprost

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00705757
Pfizer GA6111AX
No
Not Provided
Not Provided
Deepak P. Edward, Summa Health System
Summa Health System
Not Provided
Principal Investigator: Deepak P Edward, MD Summa Health System
Principal Investigator: Smajo Osmanovic, MD Arlington eye Associates
Summa Health System
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP