Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

• 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: Allergan
• 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 ]
• 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

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

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