Overview

This trial is active, not recruiting.

Conditions glaucoma, periocular skin pigmentation changes
Treatments latanoprost, bimatoprost, travoprost
Phase phase 4
Sponsor Summa Health System
Start date March 2008
End date December 2012
Trial size 75 participants
Trial identifier NCT00705757, Pfizer GA6111AX

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients assigned to Lumigan
bimatoprost Lumigan
0.03% Bimatoprost ophthalmic sol. one drop qhs for one year
(Active Comparator)
Patients assigned to Xalatan
latanoprost Xalatan
0.005% ophthalmic sol. one drop qhs for one year
(Active Comparator)
Patients assigned to Travatan
travoprost Travatan
0.004% ophthalmic sol., one drop qhs for one year

Primary Outcomes

Measure
skin pigmentation changes
time frame: one year

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation
Principal investigator Deepak P Edward, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Summa Health System.