Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension
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
1 other identifier
interventional
750
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2015
Typical duration for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedStudy Start
First participant enrolled
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2018
CompletedJuly 5, 2018
July 1, 2018
2.6 years
October 7, 2015
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
24 Weeks
Study Arms (1)
GANFORT®
OTHEROne drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks.
Interventions
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (15)
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Tongren hospital Capital Medical University
Beijing, Beijing Municipality, 100730, China
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Henan Provincial Eye Hospital
Henan, Zhengzhou, 450003, China
Related Publications (1)
Sun X, Yao K, Liu Q, Zhang H, Xing X, Fang A, Duan X, Yu M, Chen MY, Yang J, Goodkin ML. Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2023 Feb;12(1):341-353. doi: 10.1007/s40123-022-00593-w. Epub 2022 Nov 12.
PMID: 36370233DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne McLaughlin
Allergan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 8, 2015
Study Start
November 10, 2015
Primary Completion
June 21, 2018
Study Completion
June 21, 2018
Last Updated
July 5, 2018
Record last verified: 2018-07