Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 24, 2008
December 14, 2012
March 2008
December 2012   (final data collection date for primary outcome measure)
skin pigmentation changes [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00705757 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
  • Periocular Skin Pigmentation Changes
  • Drug: Latanoprost
    0.005% ophthalmic sol. one drop qhs for one year
    Other Name: Xalatan
  • Drug: Bimatoprost
    0.03% Bimatoprost ophthalmic sol. one drop qhs for one year
    Other Name: Lumigan
  • Drug: Travoprost
    0.004% ophthalmic sol., one drop qhs for one year
    Other Name: Travatan
  • Active Comparator: 1
    Patients assigned to Lumigan
    Intervention: Drug: Bimatoprost
  • Active Comparator: 2
    Patients assigned to Xalatan
    Intervention: Drug: Latanoprost
  • Active Comparator: 3
    Patients assigned to Travatan
    Intervention: Drug: Travoprost

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
December 2012
December 2012   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00705757
Pfizer GA6111AX
No
DEdward, 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 2012

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