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Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
bimatoprost 0.03% plus timolol 0.5%
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital
  • Xuanwu Hospital Capital Medical University
  • Peking University Third Hospital
  • Beijing Tongren hospital Capital Medical University
  • Zhongshan Ophthalmic Center, Sun Yat-Sen University
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
  • Second Xiangya Hospital of Central South University
  • Jiangsu Province Hospital
  • Eye & ENT Hospital of Fudan University
  • West China Hospital, Sichuan University
  • Tianjin Eye Hospital
  • Tianjin Medical University Eye Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Eye Hospital of Wenzhou Medical University
  • Henan Provincial Eye Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GANFORT®

Arm Description

One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks.

Outcomes

Primary Outcome Measures

Incidence of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
October 7, 2015
Last Updated
July 3, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02571712
Brief Title
Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2015 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GANFORT®
Arm Type
Other
Arm Description
One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% plus timolol 0.5%
Other Intervention Name(s)
GANFORT®
Intervention Description
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne McLaughlin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Tongren hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300384
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Eye Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Henan Provincial Eye Hospital
City
Henan
State/Province
Zhengzhou
ZIP/Postal Code
450003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36370233
Citation
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.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

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Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

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