Phase 4
N=89
The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
Glaucoma · Application Site Pigmentation Changes
Bottom Line
View on ClinicalTrials.gov: NCT00705757 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: 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. — -0.90; -1.42; -0.90; -0.37 L*a*b* — p=0.769
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- latanoprost (Drug); bimatoprost (Drug); travoprost (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Summa Health System
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-0.90; -1.42; -0.90; -0.37; 0.48; 0.17 | 0.769 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00705757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.