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Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191008
First Posted: August 30, 2010
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 22, 2016  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Glaucoma
Ocular Hypertension
Intervention: Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 661 participants were registered in the study. Of the 661 participants, 28 participants were excluded from the study because their case report forms were not collected. Finally, 633 participants were included in the study.

Reporting Groups
  Description
Latanoprost/Timolol Maleate Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.

Participant Flow:   Overall Study
    Latanoprost/Timolol Maleate
STARTED   633 
COMPLETED   618 
NOT COMPLETED   15 
Protocol Violation                7 
Lost to Follow-up                8 



  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.
A total of 661 participants were registered in the study. 28 participants were excluded from the study because their case report forms were not collected.Of the 633 participants, 15 participants were excluded from the baseline analysis due to following reasons: protocol violation (7 participants) and lost to follow-up (8 participants).

Reporting Groups
  Description
Latanoprost/Timolol Maleate Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks.

Baseline Measures
   Latanoprost/Timolol Maleate 
Overall Participants Analyzed 
[Units: Participants]
 618 
Age, Customized 
[Units: Participants]
 
>=15 and <65 years   227 
˃=65 years   391 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      329  53.2% 
Male      289  46.8% 


  Outcome Measures
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1.  Primary:   Number of Participants WithTreatment-Related Adverse Events   [ Time Frame: Max 104 weeks ]

2.  Primary:   Clinical Effectiveness Rate   [ Time Frame: Max 104 weeks ]

3.  Other Pre-specified:   Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert   [ Time Frame: Max 104 weeks ]


  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 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.


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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01191008     History of Changes
Other Study ID Numbers: A6641056
First Submitted: August 26, 2010
First Posted: August 30, 2010
Results First Submitted: December 22, 2016
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017



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