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Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01026831
First received: December 2, 2009
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
Results First Received: August 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Open-angle Glaucoma
Ocular Hypertension
Interventions: Drug: Preservative-Free Tafluprost
Drug: Comparator: timolol

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tafluprost One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
Timolol Maleate One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.

Participant Flow:   Overall Study
    Tafluprost     Timolol Maleate  
STARTED     320 [1]   323 [1]
COMPLETED     306     312  
NOT COMPLETED     14     11  
Adverse Event                 4                 3  
Lost to Follow-up                 2                 0  
Physician Decision                 1                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 7                 5  
[1] randomized



  Baseline Characteristics
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Reporting Groups
  Description
Tafluprost One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
Timolol Maleate One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Tafluprost     Timolol Maleate     Total  
Number of Participants  
[units: participants]
 		  320     323     643  
Age  
[units: years]
Mean ± Standard Deviation 		  63.3  ± 11.7     63.3  ± 11.6     63.3  ± 11.6  
Gender  
[units: participants]
 		     
Female     183     192     375  
Male     137     131     268  



  Outcome Measures
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1.  Primary:   Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)   [ Time Frame: Baseline, Weeks 2, 6, and 12. ]
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2.  Other Pre-specified:   Baseline IOP   [ Time Frame: Baseline ]
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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:
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
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Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01026831     History of Changes
Other Study ID Numbers: MK-2452-001, 2009_701
Study First Received: December 2, 2009
Results First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration