A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00527592
First received: September 10, 2007
Last updated: May 11, 2012
Last verified: May 2012
Results First Received: November 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Interventions: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

  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
Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
54 patients were enrolled in the study. Qualified patients ceased prostaglandin use for 3-5 days (wash-out) prior to Visit 2 (randomization).

Reporting Groups
  Description
Travoprost/Latanoprost Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.

Participant Flow:   Overall Study
    Travoprost/Latanoprost  
STARTED     54  
COMPLETED     54  
NOT COMPLETED     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
Travoprost/Latanoprost Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.

Baseline Measures
    Travoprost/Latanoprost  
Number of Participants  
[units: participants]
  54  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     24  
Gender  
[units: participants]
 
Female     37  
Male     17  



  Outcome Measures

1.  Primary:   Comfort Immediately After Dosing   [ Time Frame: 5 seconds ]


  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
None specified.


  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: Director of Medical Affairs
Organization: Alcon Research, Ltd.
phone: 1-800-862-5266
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00527592     History of Changes
Other Study ID Numbers: SMA-07-01
Study First Received: September 10, 2007
Results First Received: November 13, 2009
Last Updated: May 11, 2012
Health Authority: United States: Institutional Review Board