An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01735214
First received: November 26, 2012
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: April 10, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Intervention: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patients With POAG or OHT Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Participant Flow:   Overall Study
    Patients With POAG or OHT  
STARTED     358  
COMPLETED     358  
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.
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Reporting Groups
  Description
Patients With POAG or OHT Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Baseline Measures
    Patients With POAG or OHT  
Number of Participants  
[units: participants]
  358  
Age, Customized  
[units: participants]
 
18 to 30 years     10  
31 to 40 years     9  
41 to 50 years     28  
51 to 60 years     89  
61 to 70 years     125  
71 to 80 years     81  
81 to 90 years     16  
Gender  
[units: Participants]
 
Female     180  
Male     178  



  Outcome Measures
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1.  Primary:   Change From Baseline in Intraocular Pressure (IOP) in the Right Eye   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Change From Baseline in Intraocular Pressure (IOP) in the Left Eye   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale   [ Time Frame: 12 Weeks ]

4.  Secondary:   Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale   [ Time Frame: 12 Weeks ]

5.  Secondary:   Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks   [ Time Frame: 12 Weeks ]

6.  Secondary:   Percentage of Participants Who Continue the New Treatment After 12 Weeks   [ Time Frame: 12 Weeks ]

7.  Secondary:   Physician Assessment of Adherence to New Treatment Using a 4-Point Scale   [ Time Frame: 12 Weeks ]

8.  Secondary:   Physician Assessment of Efficacy Using a 5-Point Scale   [ Time Frame: 12 Weeks ]

9.  Secondary:   Percentage of Participants Reaching Individual IOP Target After 12 Weeks   [ Time Frame: 12 Weeks ]


  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 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: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01735214     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/037
Study First Received: November 26, 2012
Results First Received: April 10, 2015
Last Updated: May 20, 2015
Health Authority: Turkey: Ethics Committee