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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Glaucoma, Open-Angle
Ocular Hypertension
Intervention Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution
Enrollment 732
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combigan® Ophthalmic Solution
Hide Arm/Group Description Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Period Title: Overall Study
Started 732
Completed 732
Not Completed 0
Arm/Group Title Combigan® Ophthalmic Solution
Hide Arm/Group Description Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Overall Number of Baseline Participants 732
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 732 participants
< 50 years 140
50 - 59 years 144
60 - 69 years 219
≥ 70 years 225
Missing Data 4
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 732 participants
Female 347
Male 384
Missing Data 1
1.Primary Outcome
Title Percentage of Participants Reporting Adverse Events
Hide Description 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.
Time Frame Up to 2.6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received study drug.
Arm/Group Title Combigan® Ophthalmic Solution
Hide Arm/Group Description:
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Overall Number of Participants Analyzed 732
Measure Type: Number
Unit of Measure: Percentage of participants
6.56
2.Primary Outcome
Title Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available.
Arm/Group Title Combigan® Ophthalmic Solution
Hide Arm/Group Description:
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Overall Number of Participants Analyzed 699
Measure Type: Number
Unit of Measure: Percentage of participants
85.69
Time Frame Adverse Events were assessed for up to 2.6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combigan® Ophthalmic Solution
Hide Arm/Group Description Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
All-Cause Mortality
Combigan® Ophthalmic Solution
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Combigan® Ophthalmic Solution
Affected / at Risk (%)
Total   0/732 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combigan® Ophthalmic Solution
Affected / at Risk (%)
Total   0/732 (0.00%) 
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President GSE,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01987752    
Other Study ID Numbers: 190342-040
First Submitted: November 13, 2013
First Posted: November 19, 2013
Results First Submitted: February 25, 2014
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014