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CompletedNCT02571712Updated Jul 5, 2018

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

A Phase 4 interventional study of bimatoprost 0.03% plus timolol 0.5% in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Allergan. Completed at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Allergan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
750
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Glaucoma, Open-Angle
  • Ocular Hypertension
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 750 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
750 participants (actual)

Study arms

  • Other
    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.

    Drug: bimatoprost 0.03% plus timolol 0.5%

Interventions

  • Drugbimatoprost 0.03% plus timolol 0.5%

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

    Also known as: GANFORT®

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What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 24 Weeks

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Study locations

15 sites
  • Beijing Hospital
    Beijing, Beijing 100005, China
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing 100053, China
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
  • Beijing Tongren hospital Capital Medical University
    Beijing, Beijing 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 200031, China
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
  • Tianjin Eye Hospital
    Tianjin, Tianjin 300020, China
  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin 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
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References and documents

Publications

  • 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. PubMed 36370233 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02571712
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Oct 8, 2015
Start date
Nov 10, 2015
Primary completion
Jun 21, 2018
Completion
Jun 21, 2018
Last update
Jul 5, 2018

Study contacts

Anne McLaughlin
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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