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

Summa Health System

Status and phase: Completed; Phase 4

Conditions: Application Site Pigmentation Changes; Glaucoma

Treatments: Drug: latanoprost; Drug: travoprost; Drug: bimatoprost

Study type: Interventional

Funder types: Other

Identifiers

NCT00705757

Pfizer GA6111AX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 3 patient groups

Lumigan

Active Comparator group

Description:

Patients assigned to Lumigan/bimatoprost one drop before bedtime (qhs) to affected eye(s)

Treatment:

Drug: bimatoprost

Xalatan

Active Comparator group

Description:

Patients assigned to Xalatan/latanoprost one drop before bedtime (qhs) to affected eye(s)

Treatment:

Drug: latanoprost

Travatan

Active Comparator group

Description:

Patients assigned to Travatan/travoprost one drop before bedtime (qhs) to affected eye(s)

Treatment:

Drug: travoprost