Travoprost Five Day Posology Study

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01114893
First received: April 30, 2010
Last updated: May 26, 2011
Last verified: May 2011
Results First Received: May 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Open-angle Glaucoma (OAG)
Ocular Hypertension
Interventions: Drug: Travoprost 0.004%
Drug: Travoprost Vehicle
Drug: Travoprost (Groups A, B and C)

  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
TRAVATAN TRAVATAN 0.004% once daily
Travoprost Vehicle Travoprost Vehicle
Travoprost Group A Travoprost Group A
Travoprost Group B Travoprost Group B
Travoprost Group C Travoprost Group C

Participant Flow:   Overall Study
    TRAVATAN     Travoprost Vehicle     Travoprost Group A     Travoprost Group B     Travoprost Group C  
STARTED     14     14     14     13     12  
COMPLETED     14     14     14     13     12  
NOT COMPLETED     0     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
TRAVATAN TRAVATAN 0.004% once daily
Travoprost Vehicle Travoprost Vehicle
Travoprost Group A Travoprost Group A
Travoprost Group B Travoprost Group B
Travoprost Group C Travoprost Group C
Total Total of all reporting groups

Baseline Measures
    TRAVATAN     Travoprost Vehicle     Travoprost Group A     Travoprost Group B     Travoprost Group C     Total  
Number of Participants  
[units: participants]
  14     14     14     13     12     67  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     8     8     9     4     3     32  
>=65 years     6     6     5     9     9     35  
Gender  
[units: participants]
           
Female     7     7     6     9     8     37  
Male     7     7     8     4     4     30  



  Outcome Measures
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1.  Primary:   Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5   [ Time Frame: 5 days ]

2.  Secondary:   IOP Change From Baseline at 8 PM on Day 5   [ Time Frame: 5 Days ]


  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, Lt.d
phone: 888.451.3937 ext 817.568.67
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Matt Walker, PhD, Alcon Research, Ltd
ClinicalTrials.gov Identifier: NCT01114893     History of Changes
Other Study ID Numbers: C-09-075
Study First Received: April 30, 2010
Results First Received: May 26, 2011
Last Updated: May 26, 2011
Health Authority: United States: Food and Drug Administration