A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00383019

First received: September 29, 2006

Last updated: August 3, 2009

Last verified: August 2009

History of Changes

Results First Received: October 1, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Glaucoma, Primary Open Angle (POAG) Ocular Hypertension
Interventions:	Drug: Xalacom (KP2035) Drug: Xalatan

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
55 centers in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
300 subjects were treated with Xalatan in Run-in period. (Run-in period: subjects treated with Xalatan (0.005% latanoprost eye drop), one drop, once daily in the evening (20:00-23:00).) Of these, 289 subjects were assigned to groups (144 in KP2035 group and 145 in Xalatan group).

Reporting Groups

	Description
KP2035 Group	Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
Xalatan Group	Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).

Participant Flow: Overall Study

	KP2035 Group	Xalatan Group
STARTED	144	145
COMPLETED	139	143
NOT COMPLETED	5	2
Adverse Event	5	1
Withdrawal by Subject	0	1

Baseline Characteristics

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Reporting Groups

	Description
KP2035 Group	Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
Xalatan Group	Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
Total	Total of all reporting groups

Baseline Measures

	KP2035 Group	Xalatan Group	Total
Number of Participants [units: participants]	144	145	289
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	78	77	155
>=65 years	66	68	134
Gender [units: participants]
Female	70	74	144
Male	74	71	145
Region of Enrollment [units: participants]
Japan	144	145	289

Outcome Measures

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1. Primary:

Change of Intraocular Pressure (IOP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

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2. Secondary:

Change of IOP From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]

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3. Secondary:

Percent Change of IOP From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

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Measure Type	Secondary
Measure Title	Percent Change of IOP From Baseline to Week 8
Measure Description	Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100
Time Frame	Baseline to Week 8
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.
The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.

Reporting Groups

	Description
KP2035 Group	Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
Xalatan Group	Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).

Measured Values

	KP2035 Group	Xalatan Group
Number of Participants Analyzed [units: participants]	144	145
Percent Change of IOP From Baseline to Week 8 [units: percent change] Least Squares Mean ( 95% Confidence Interval )	-12.67 ( -14.40 to -10.93 )	-7.69 ( -9.42 to -5.95 )

Statistical Analysis 1 for Percent Change of IOP From Baseline to Week 8

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-4.98
95% Confidence Interval	( -7.43 to -2.52 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The analysis of covariance (ANCOVA) was applied using the treatment groups as a factor and baseline IOP of the study eyes as a covariate.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.
[4]	Other relevant estimation information:
	Mean difference was calculated as "percent change from baseline to Week 8 in KP2035 group" minus "percent change from baseline to Week 8 in Xalatan group".

4. Secondary:

Number of Subjects With an IOP of <=15 mmHg at Week 8 [ Time Frame: Week 8 ]

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5. Secondary:

Number of Subjects With an IOP of <=16 mmHg at Week 8 [ Time Frame: Week 8 ]

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6. Secondary:

Number of Subjects With an IOP of <=17 mmHg at Week 8 [ Time Frame: Week 8 ]

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7. Secondary:

Number of Subjects With an IOP of <=18 mmHg at Week 8 [ Time Frame: Week 8 ]

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8. Secondary:

Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

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9. Secondary:

Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

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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: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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
Not applicable

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00383019 History of Changes
Other Study ID Numbers:	A6641050
Study First Received:	September 29, 2006
Results First Received:	October 1, 2008
Last Updated:	August 3, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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