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

NCT ID: NCT02571712

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-10

Study Completion Date

2018-06-21

Brief Summary

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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

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

bimatoprost 0.03% plus timolol 0.5%

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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GANFORT®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne McLaughlin

Role: STUDY_DIRECTOR

Allergan

Locations

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Beijing Hospital

Beijing, Beijing Municipality, China

Site Status

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Tongren hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Site Status

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Henan Provincial Eye Hospital

Henan, Zhengzhou, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36370233 (View on PubMed)

Related Links

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Other Identifiers

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192024-094

Identifier Type: -

Identifier Source: org_study_id

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