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

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: bimatoprost 0.03% plus timolol 0.5%

• Registration Number: NCT02571712
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2015-11-10
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	24 Weeks

Trial Locations

Locations (15)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tongren hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Zhongshan Ophthalmic Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, Tianjin, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Eye Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Henan Provincial Eye Hospital; 🇨🇳 Henan, Zhengzhou, China