Glaucoma, Open-AnglePhase 4NCT02571712
Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension
A Phase 4 study testing bimatoprost 0.03% plus timolol 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 15 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- bimatoprost 0.03% plus timolol 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 15 sitesChina
- Study dates
- 10 Nov 2015to 21 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Hospital
Beijing, Beijing Municipality, 100005
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Tongren hospital Capital Medical University
Beijing, Beijing Municipality, 100730
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Henan Provincial Eye Hospital
Henan, Zhengzhou, 450003
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
About this study
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
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.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- bimatoprost 0.03% plus timolol 0.5%
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 0.03% plus timolol 0.5%Drug
Also called GANFORT®
1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
| Study group | Role | What they receive |
|---|---|---|
| GANFORT® | Other | One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks. Receives: Drug: bimatoprost 0.03% plus timolol 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start10 Nov 2015
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne McLaughlin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571712
- Sponsor's protocol ID
- 192024-094
- Status last verified
- Jul 2018
- First submitted
- 7 Oct 2015
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02571712
- Acronym / sponsor ID
- 192024-094
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GANFORT® | Other | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimatoprost 0.03% plus timolol 0.5%Also: GANFORT®1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily. | Drug | GANFORT® |
Primary outcome
Incidence of Adverse Events
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Derived from this study: PubMed 36370233Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne McLaughlin study director
Allergan
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bimatoprost 0.03% plus timolol 0.5% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.