- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571712
Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension
July 3, 2018 updated by: Allergan
Evaluation of the Safety of GANFORT® (Bimatoprost 0.03% Plus Timolol 0.5%) Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension
A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
750
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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Beijing, Beijing, China, 100053
- Xuanwu Hospital Capital Medical University
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Beijing, Beijing, China, 100005
- Beijing Hospital
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Beijing, Beijing, China, 100730
- Beijing Tongren Hospital Capital Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
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Hunan
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Changsha, Hunan, China, 410011
- Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
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Shanghai
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Shanghai, Shanghai, China, 200031
- Eye & ENT Hospital of Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Tianjin
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Tianjin, Tianjin, China, 300384
- Tianjin Medical University Eye Hospital
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Tianjin, Tianjin, China, 300020
- TianJin eye hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Wenzhou, Zhejiang, China, 325027
- Eye Hospital of Wenzhou Medical University
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Zhengzhou
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Henan, Zhengzhou, China, 450003
- Henan Provincial Eye Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes
- Is willing to stop other intraocular pressure (IOP)-lowering medications and switch to GANFORT® as a single agent in affected eye(s).
Exclusion Criteria:
- Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease
- Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: GANFORT®
One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks.
|
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Adverse Events
Time Frame: 24 Weeks
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24 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anne McLaughlin, Allergan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2015
Primary Completion (Actual)
June 21, 2018
Study Completion (Actual)
June 21, 2018
Study Registration Dates
First Submitted
October 7, 2015
First Submitted That Met QC Criteria
October 7, 2015
First Posted (Estimate)
October 8, 2015
Study Record Updates
Last Update Posted (Actual)
July 5, 2018
Last Update Submitted That Met QC Criteria
July 3, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Bimatoprost
Other Study ID Numbers
- 192024-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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