Full Text View
Tabular View
Study Results
Related Studies
MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension
This study has been completed.
Study NCT00449956   Information provided by Merck
First Received: March 19, 2007   Last Updated: November 6, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition: Glaucoma
Interventions: Drug: dorzolamide hydrochloride (+) timolol maleate
Drug: Comparator: timolol maleate
Drug: Comparator: dorzolamide hydrochloride

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III. Studied period: April 9, 2007 (date study therapy started for the first subject) to February 16, 2008 (the last subject’s last visit stipulated in study protocol). Study was conducted at 67 clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outpatients with primary open angle glaucoma (broad definition) and/or ocular hypertension received 4-week timolol 0.5% monotherapy in the wash-out period before the study randomization.

Reporting Groups
  Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Participant Flow:   Overall Study
  MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) Timolol 0.5% Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
STARTED   189     92     193  
COMPLETED   179     88     184  
NOT COMPLETED   10     4     9  
      Adverse Event               7                 1                 6  
      Lack of Efficacy               0                 0                 1  
      Protocol Violation               1                 1                 1  
      Withdrawal by Subject               0                 1                 0  
      Physician Decision               2                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Baseline Measures
  MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) Timolol 0.5% Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Total
Number of Participants  
[units: participants]
 		189 92 193 474
Age  
[units: Years]
Mean ± Standard Deviation 		63.2 ± 10.8 61.3 ± 11.6 62.3 ± 12.7 62.4 ± 11.7
Age, Customized  
[units: participants]
 		       
<65 years 92 50 102 244
>=65 years 97 42 91 230
Gender  
[units: participants]
 		       
Female 104 43 98 245
Male 85 49 95 229
Diagnosis  
[units: participants]
 		       
Open-angle glaucoma 107 51 90 248
Normal-tension glaucoma 8 6 4 18
Ocular hypertension 74 35 99 208
Intraocular pressure (IOP) at Hour 2  
[units: mmHg]
Mean ± Standard Deviation 		20.54 ± 2.07 20.23 ± 1.85 20.38 ± 2.31 20.42 ± 2.13



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks   [ 8 weeks ]

Measure Type Primary
Measure Title Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
Measure Description Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Time Frame 8 weeks  
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.
Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).

Reporting Groups
  Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Measured Values
  MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) Timolol 0.5% Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Number of Participants Analyzed
[units: participants] 		185 90 188
Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
[units: mmHg]
Least Squares Mean ( 95% Confidence Interval ) 		-2.50
( -2.86 to -2.15 )		 -1.82
( -2.33 to -1.31 )		 -2.78
( -3.13 to -2.43 )


Statistical Analysis 1 for Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
Groups [1] MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) vs. Timolol 0.5%
Mean Difference (Final Values) [2] -0.68
95% Confidence Interval ( -1.30 to -0.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.

Statistical Analysis 2 for Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
Groups [1] MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) vs. Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Final Values) [3] 0.28
95% Confidence Interval ( -0.22 to 0.78 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin = 1.2 mmHg
[3] Other relevant estimation information:
  An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.



2.  Secondary:   Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks   [ 8 Weeks ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
Measure Description Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
Time Frame 8 Weeks  
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.
Last observed value during the 8-week treatment period was used in the FAS.

Reporting Groups
  Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Measured Values
  MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) Timolol 0.5% Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Number of Participants Analyzed
[units: participants] 		185 90 188
Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks
[units: Percent Change]
Least Squares Mean ( 95% Confidence Interval ) 		-11.99
( -13.69 to -10.28 )		 -8.74
( -11.18 to -6.30 )		 -13.46
( -15.15 to -11.77 )

No statistical analysis provided for Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks



3.  Secondary:   Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks   [ 8 weeks ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
Measure Description Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)
Time Frame 8 weeks  
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.
Last observed value during the 8-week treatment period was used in the FAS.

Reporting Groups
  Description
MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
Timolol 0.5% Timolol 0.5%, one drop per dose twice daily to the study eye.
Concomitant (Dorzolamide 1.0% / Timolol 0.5%) Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).

Measured Values
  MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination) Timolol 0.5% Concomitant (Dorzolamide 1.0% / Timolol 0.5%)
Number of Participants Analyzed
[units: participants] 		185 90 188
Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks
[units: Percent Change]
Least Squares Mean ( 95% Confidence Interval ) 		23.47
( 20.07 to 26.88 )		 17.17
( 12.29 to 22.05 )		 26.75
( 23.37 to 30.12 )

No statistical analysis provided for Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_011, MK0507A-149
Study First Received: March 19, 2007
Results First Received: January 23, 2009
Last Updated: November 6, 2009
ClinicalTrials.gov Identifier: NCT00449956     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services