Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763061
First received: September 26, 2008
Last updated: February 23, 2010
Last verified: February 2010
Results First Received: April 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)
Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)

  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
111 patients were enrolled in this study at 4 hospitals

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility patients were washed out for up to 4 weeks before randomization

Reporting Groups
  Description
Travoprost 0.004% Travoprost at 9 AM + Placebo & 9 PM
Timolol 0.5% Timolol in each eye, twice daily at 9 AM & 9 PM

Participant Flow:   Overall Study
    Travoprost 0.004%     Timolol 0.5%  
STARTED     54     57  
COMPLETED     49     44  
NOT COMPLETED     5     13  



  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.
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Reporting Groups
  Description
Travoprost 0.004% Travoprost at 9 AM + Placebo & 9 PM
Timolol 0.5% Timolol in each eye, twice daily at 9 AM & 9 PM
Total Total of all reporting groups

Baseline Measures
    Travoprost 0.004%     Timolol 0.5%     Total  
Number of Participants  
[units: participants]
  54     57     111  
Age  
[units: participants]
     
<=18 years     2     1     3  
Between 18 and 65 years     33     31     64  
>=65 years     19     25     44  
Gender  
[units: participants]
     
Female     22     26     48  
Male     32     31     63  



  Outcome Measures
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1.  Primary:   Mean Intraocular Pressure (IOP) at 9 AM   [ Time Frame: At Week 12 - At the 9 AM time point for the patient's worse eye. ]

2.  Primary:   Week 12 - Mean IOP At 4 PM   [ Time Frame: At the 4 PM time point for the patient's worse eye. ]

3.  Secondary:   Mean IOP Change From Baseline at 9 AM   [ Time Frame: Baseline to Week 12 - at 9 AM ]

4.  Secondary:   Mean IOP Change at 4 PM   [ Time Frame: Baseline to Week 12 - at 4 PM ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Benny Li, Ph.D., Alcon Research Ltd
ClinicalTrials.gov Identifier: NCT00763061     History of Changes
Other Study ID Numbers: MS-06-02
Study First Received: September 26, 2008
Results First Received: April 28, 2009
Last Updated: February 23, 2010
Health Authority: Hong Kong: Department of Health