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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deepak P. Edward, Summa Health System
ClinicalTrials.gov Identifier:
NCT00705757
First received: June 24, 2008
Last updated: December 14, 2015
Last verified: December 2015
Results First Received: December 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Glaucoma
Application Site Pigmentation Changes
Interventions: Drug: latanoprost
Drug: bimatoprost
Drug: travoprost

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)

Participant Flow:   Overall Study
    Lumigan     Xalatan     Travatan  
STARTED     32     29     28  
COMPLETED     19     21     17  
NOT COMPLETED     13     8     11  
Lack of Efficacy                 5                 1                 3  
Lost to Follow-up                 7                 6                 6  
Withdrawal by Subject                 1                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
Total Total of all reporting groups

Baseline Measures
    Lumigan     Xalatan     Travatan     Total  
Number of Participants  
[units: participants]
  19     21     17     57  
Age  
[units: years]
Mean (Full Range)
  61.5  
  (41 to 78)  
  59.2  
  (30 to 81)  
  60.5  
  (39 to 73)  
  60.4  
  (30 to 81)  
Gender  
[units: participants]
       
Female     10     8     9     27  
Male     9     13     8     30  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     4     2     4     10  
White     15     19     13     47  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  



  Outcome Measures

1.  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.   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Deepak P. Edward, MD
Organization: Summa Health System ( at the time of the trial)
phone: 330-780-0399
e-mail: deepak.edward@gmail.com


Publications:
Lee JA, Osmanovic S, Viana MAG, Kapur R, Meghpara B, Edward DP.Objective measurement of Periocular Pigmentation. Invest. Ophthalmol. Vis Sci. 2006 47: E-Abstract 462


Responsible Party: Deepak P. Edward, Summa Health System
ClinicalTrials.gov Identifier: NCT00705757     History of Changes
Other Study ID Numbers: Pfizer GA6111AX
Study First Received: June 24, 2008
Results First Received: December 25, 2014
Last Updated: December 14, 2015
Health Authority: United States: Institutional Review Board