Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

NCT01987752 | Completed Results

• 1 other identifier: 190342-040
• Study Type: observational
• Target: 732
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Reporting Adverse Events

  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.

  Up to 2.6 Years

• Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)

  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.

  Baseline, Week 4

Study Arms (1)

Combigan® Ophthalmic Solution

Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.

Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution

Interventions

brimonidine tartrate/timolol maleate Ophthalmic Solution DRUG

brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.

Also known as: Combigan®

Combigan® Ophthalmic Solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Brimonidine Tartrate; Brimonidine Tartrate, Timolol Maleate Drug Combination

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Timolol; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Vice President GSE,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 4, 2014
• Results First Posted: April 4, 2014

Record last verified: 2014-02

Locations

KR (1)