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NCT02571712 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02571712
Other study ID # 192024-094
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 10, 2015
Est. completion date June 21, 2018

Study information
Verified date July 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date June 21, 2018
Est. primary completion date June 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• bimatoprost 0.03% plus timolol 0.5%
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.

Locations
Country Name City State
China Beijing Hospital Beijing Beijing
China Beijing Tongren hospital Capital Medical University Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China Xuanwu Hospital Capital Medical University Beijing Beijing
China Second Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital, Sichuan University Chengdu Sichuan
China Zhongshan Ophthalmic Center, Sun Yat-Sen University Guangzhou Guangdong
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Henan Provincial Eye Hospital Henan Zhengzhou
China Jiangsu Province Hospital Nanjing Jiangsu
China Eye & ENT Hospital of Fudan University Shanghai Shanghai
China Tianjin Eye Hospital Tianjin Tianjin
China Tianjin Medical University Eye Hospital Tianjin Tianjin
China Eye Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events 24 Weeks
See also
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
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Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
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Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4

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