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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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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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
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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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