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Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

This study has been completed.
Sponsor:
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
NCT00918346
First received: June 9, 2009
Last updated: December 10, 2010
Last verified: December 2010
History of Changes
Results First Received: August 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Intervention: Drug: Tafluprost 0.0015%

  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

At 2 centers in Germany, 1 center in Finland:

14 September 2005 first patient screened 08 November 2005 first patient randomized 05 April 2006 last patient completed

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 45 patients screened and 43 patients randomized. 2 screening failure patients: 1 withdrawn consent and 1 too low IOP (inclusion criterion 4).

Reporting Groups
  Description
Preserved Formulation First, Then Unpreserved Formulation Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
Unpreserved Formulation First, Then Preserved Formulation Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)

Participant Flow for 4 periods

 Period 1:   First Treatment Period (4 Weeks)
    Preserved Formulation First, Then Unpreserved Formulation     Unpreserved Formulation First, Then Preserved Formulation  
STARTED     21     22  
COMPLETED     21     21 [1]
NOT COMPLETED     0     1  
Lack of Efficacy                 0                 1  
[1] A patient completed the first treatment period but discontinued thereafter (did not start washout).

Period 2:   Washout (at Least 4 Weeks)
    Preserved Formulation First, Then Unpreserved Formulation     Unpreserved Formulation First, Then Preserved Formulation  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 3:   Second Treatment Period (4 Weeks)
    Preserved Formulation First, Then Unpreserved Formulation     Unpreserved Formulation First, Then Preserved Formulation  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  

Period 4:   Post Study Period
    Preserved Formulation First, Then Unpreserved Formulation     Unpreserved Formulation First, Then Preserved Formulation  
STARTED     21     21  
COMPLETED     21     21  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population Includes all 43 randomized patients (86 eyes)

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  43  
Age  
[units: years]
Mean ± Standard Deviation 		  65.3  ± 10.1  
Gender  
[units: participants]
 		 
Female     27  
Male     16  
Race/Ethnicity, Customized  
[units: participants]
 		 
Caucasian     43  
Region of Enrollment  
[units: participants]
 		 
Germany     32  
Finland     11  
Diagnosis - worse eyes [1]
[units: eyes]
 		 
Primary Open Angle Glaucoma     28  
Capsular Glaucoma     3  
Ocular Hypertension     12  
Central corneal thickness  
[units: micrometer]
Mean ± Standard Deviation 		 
Right eye     548.7  ± 42.8  
Left eye     547.0  ± 45.4  
[1] Worse eye: If both eyes satisfied the inclusion criteria, then the worse eye was the eye with the higher intraocular pressure at the 8:00 IOP measurement at the first baseline visit. In case both eyes had the same IOP, then the right eye was designated as the worse eye. If only one eye satisfied the inclusion criteria, then that eye was considered to be the worse eye.



  Outcome Measures
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1.  Primary:   Intraocular Pressures (IOPs) at Baseline   [ Time Frame: Baseline ]
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2.  Primary:   Intraocular Pressures (IOPs) at Week 1   [ Time Frame: Week 1 ]
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3.  Primary:   Intraocular Pressures (IOPs) at Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 3

4.  Primary:   Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)   [ Time Frame: Baseline - Week 4 ]
  Show Outcome Measure 4

5.  Primary:   Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)   [ Time Frame: Baseline - Week 4 ]
  Show Outcome Measure 5

6.  Secondary:   Overall and Time-wise Comparisons of IOP at Week 1   [ Time Frame: Baseline - Week 1 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Time-wise IOPs at Week 4   [ Time Frame: Baseline - Week 4 ]
  Show Outcome Measure 7


  Serious Adverse Events
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Time Frame Adverse event data was collected at Week 1 and Week 4 visits of treatment period I and II, as well as on last Post-study visit. Additionally, baseline symptoms were queried on Day 0 (=Baseline) visit of the two treatment periods.
Additional Description Patients were asked about ocular or non-ocular symptoms with a non-leading question, or they volunteered the information during a study visit. Also, any clinically significant signs observed by the investigator could be recorded as adverse events.

Reporting Groups
  Description
Preserved Formulation Tafluprost 0.0015% preserved formulation once daily for 4 weeks
Unpreserved Formulation Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks

Serious Adverse Events
    Preserved Formulation     Unpreserved Formulation  
Total, serious adverse events      
# participants affected / at risk     0/42 (0.00%)     0/43 (0.00%)  




  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Auli Ropo
Organization: Santen Oy
phone: +358405012416
e-mail: auli.ropo@santen.fi


No publications provided


Responsible Party: Auli Ropo, MD, PhD, Santen Oy
ClinicalTrials.gov Identifier: NCT00918346     History of Changes
Other Study ID Numbers: 77550
Study First Received: June 9, 2009
Results First Received: August 4, 2009
Last Updated: December 10, 2010
Health Authority: Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices