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

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A total of 45 patients screened and 43 patients randomized. 2 screening failure patients: 1 withdrawn consent and 1 too low IOP (inclusion criterion 4).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 ]

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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 ]

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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 ]

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6. Secondary:

Overall and Time-wise Comparisons of IOP at Week 1 [ Time Frame: Baseline - Week 1 ]

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7. Secondary:

Change From Baseline in Time-wise IOPs at Week 4 [ Time Frame: Baseline - Week 4 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Time-wise IOPs at Week 4
Measure Description	The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
Time Frame	Baseline - Week 4
Safety Issue	No

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.
ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.

Reporting Groups

	Description
RM ANCOVA: ITT Efficacy Dataset	randomized and received study medication

Measured Values

	RM ANCOVA: ITT Efficacy Dataset
Number of Participants Analyzed [units: participants]	43
Change From Baseline in Time-wise IOPs at Week 4 [units: mmHg] Mean ( 95% Confidence Interval )
Timepoint 8:00	0.24 ( -0.51 to 0.98 )
Timepoint 12:00	0.11 ( -0.64 to 0.86 )
Timepoint 16:00	0.00 ( -0.74 to 0.75 )
Timepoint 20:00	-0.30 ( -1.04 to 0.45 )

No statistical analysis provided for Change From Baseline in Time-wise IOPs at Week 4

Serious Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor respects the investigators' wish to publish results of the study, and will not unnecessarily restrict the spreading of information of scientific interest. However, the study may involve confidential information affecting the company's business, such as aspects related to patent application. Therefore, the investigators agree to allow the sponsor to review any manuscripts and to negotiate timing and forum of publication.

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

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