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...
Date First Received: June 24, 2008
Last Updated: June 25, 2008
Verified by: Summa Health System, June 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2008
Overall Status: Recruiting
Estimated Enrollment: 75
Brief Summary
Official Title: “The Effects of Latanoprost, Bimatoprost and Travoprost on Periocular Skin Pigmentation”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Study Primary Completion Date: December 2009
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Latanoprost
- 0.005% ophthalmic sol. one drop qhs for one year
- Drug: Bimatoprost
- 0.03% Bimatoprost ophthalmic sol. one drop qhs for one year
- Drug: Travoprost
- 0.004% ophthalmic sol., one drop qhs for one year
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Patients assigned to Lumigan
- Active Comparator: 2
- Patients assigned to Xalatan
- Active Comparator: 3
- Patients assigned to Travatan
Outcome Measures for this Clinical Trial
Primary Measures
- skin pigmentation changes
- Time Frame: one year
Safety Issue?: No
- Time Frame: one year
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Summa Health System
Overall Clinical Trial Officials and Contacts
Deepak P Edward, MD Principal Investigator Summa Health System
Overall Contact: Deepak P Edward, MD 330-375-3867 Edwardd@summa-health.org
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00705757
Study ID Number: Pfizer GA6111AX
ClinicalTrials.gov Identifier: NCT00705757
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
