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Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987752
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date November 13, 2013
First Posted Date November 19, 2013
Results First Submitted Date February 25, 2014
Results First Posted Date April 4, 2014
Last Update Posted Date April 4, 2014
Study Start Date January 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2014)
  • Percentage of Participants Reporting Adverse Events [ Time Frame: Up to 2.6 Years ]
    An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
  • Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 4 ]
    IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.
Original Primary Outcome Measures
 (submitted: November 13, 2013)
Change from Baseline in Intra-Ocular Pressure (IOP) [ Time Frame: Baseline, Week 4 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of Combigan® Ophthalmic Solution in Korea
Official Title Not Provided
Brief Summary This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.
Condition
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution
brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.
Other Name: Combigan®
Study Groups/Cohorts Combigan® Ophthalmic Solution
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Intervention: Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2013)
732
Original Actual Enrollment Same as current
Actual Study Completion Date November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.

Exclusion Criteria:

  • None.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987752
Other Study ID Numbers 190342-040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Allergan
Study Sponsor Allergan
Collaborators Not Provided
Investigators
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date February 2014