Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254604
First received: December 3, 2010
Last updated: April 9, 2014
Last verified: April 2014
Results First Received: April 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: Preservative-Free Tafluprost or vehicle
Drug: Preservative-Free Timolol maleate

  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
No text entered.

Reporting Groups
  Description
Tafluprost One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
Timolol One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.

Participant Flow:   Overall Study
    Tafluprost     Timolol  
STARTED     95     95  
Treated     93 [1]   94 [2]
COMPLETED     87     86  
NOT COMPLETED     8     9  
Lost to Follow-up                 1                 1  
Protocol Violation                 2                 2  
Withdrawal by Subject                 2                 4  
Adverse Event                 3                 2  
[1] The 2 out of 95 started who did not take study drug discontinued due to "Withdrawal by Subject"
[2] The 1 out of 95 started who did not take study drug discontinued due to "Withdrawal by Subject"



  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.
All Participants as Treated (APaT) population: All randomized participants who received at least one dose of study drug

Reporting Groups
  Description
Tafluprost One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
Timolol One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
Total Total of all reporting groups

Baseline Measures
    Tafluprost     Timolol     Total  
Number of Participants  
[units: participants]
  93     94     187  
Age  
[units: years]
Mean ± Standard Deviation
  56.7  ± 11.54     54.9  ± 13.42     55.8  ± 12.52  
Gender  
[units: participants]
     
Female     34     22     56  
Male     59     72     131  
Intraocular Pressure (IOP) - Study Eye [1]
[units: mmHg]
Mean ± Standard Deviation
  24.8  ± 3.0     24.9  ± 2.6     24.9  ± 2.8  
[1] Baseline IOP was measured at 0800, 1000 and 1600 hours; 2 values obtained at each time. If the 2 values differed by ≤2 mmHg, average of 2 was recorded; if by >2 mmHg, a 3rd measurement was made and median of 3 was recorded. Baseline IOP was mean of the values recorded at the 3 time points. One “study eye” was identified, which was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Data are for “Per Protocol” population: N=84, 84 and 168 for tafluprost, timolol and Total groups, respectively.



  Outcome Measures
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1.  Primary:   Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye   [ Time Frame: Baseline and Week 4 ]

2.  Primary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to 14 days after Week 4 visit ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to Week 4 ]

4.  Secondary:   Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye   [ Time Frame: Baseline and Week 4 ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254604     History of Changes
Other Study ID Numbers: 2452-002
Study First Received: December 3, 2010
Results First Received: April 9, 2014
Last Updated: April 9, 2014
Health Authority: India: Drugs Controller General of India