A Study of Bimatoprost 0.01% in the Clinical Setting (APPEAL-Taiwan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814761
First received: March 18, 2013
Last updated: September 28, 2015
Last verified: September 2015
Results First Received: September 28, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Intervention: Drug: Bimatoprost 0.01%

  Participant Flow
  Hide Participant Flow

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
Pts With POAG or OH (Previously Treatment Naive) Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Pts With POAG or OH (Switched Monotherapy) Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).

Participant Flow:   Overall Study
    Pts With POAG or OH (Previously Treatment Naive)     Pts With POAG or OH (Switched Monotherapy)  
STARTED     42     270  
COMPLETED     34     240  
NOT COMPLETED     8     30  
Other Reasons                 1                 10  
Ocular Adverse Event                 6                 15  
Lost to Follow-up                 1                 5  



  Baseline Characteristics
  Hide 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
  Description
Pts With POAG or OH (Previously Treatment Naive) Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Pts With POAG or OH (Switched Monotherapy) Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Total Total of all reporting groups

Baseline Measures
    Pts With POAG or OH (Previously Treatment Naive)     Pts With POAG or OH (Switched Monotherapy)     Total  
Number of Participants  
[units: participants]
  42     270     312  
Age  
[units: Years]
Mean (Standard Deviation)
  52.5  (13.65)     53.4  (14.45)     53.3  (14.33)  
Gender  
[units: Participants]
     
Female     20     114     134  
Male     22     156     178  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale   [ Time Frame: 12 Weeks ]

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

3.  Secondary:   Percentage of Patients Who Discontinue Due to an Adverse Event   [ Time Frame: 12 Weeks ]

4.  Secondary:   Overall Percent Change From Baseline in IOP   [ Time Frame: Baseline, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814761     History of Changes
Other Study ID Numbers: GMA-AP-EYE-AGN-001
Study First Received: March 18, 2013
Results First Received: September 28, 2015
Last Updated: September 28, 2015
Health Authority: Taiwan: Center for Drug Evaluation