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Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00471068
Recruitment Status : Terminated (Question raised by Ethics Committee)
First Posted : May 9, 2007
Results First Posted : January 8, 2010
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Open-angle Glaucoma
Ocular Hypertension
Interventions: Drug: Travatan
Drug: Cosopt
Drug: Placebo (Timolol Vehicle)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor’s decision.

Reporting Groups
Travatan No text entered.
Cosopt No text entered.

Participant Flow:   Overall Study
    Travatan   Cosopt
STARTED   21   25 
COMPLETED   20   24 

  Baseline Characteristics

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
Travatan No text entered.
Cosopt No text entered.
Total Total of all reporting groups

Baseline Measures
   Travatan   Cosopt   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   25   46 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   16   26 
>=65 years   11   9   20 
[Units: Participants]
Female   14   10   24 
Male   7   15   22 

  Outcome Measures

1.  Primary:   Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment   [ Time Frame: At week 0 and week 6 ]

  Serious Adverse Events

  Other Adverse Events

  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
Sample size smaller than the one defined by the protocol

  More Information

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 Labs
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00471068     History of Changes
Other Study ID Numbers: EMD-05-03
First Submitted: May 8, 2007
First Posted: May 9, 2007
Results First Submitted: October 21, 2009
Results First Posted: January 8, 2010
Last Update Posted: April 11, 2012