Glaucoma, Open-AngleNCT01976624
Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in South Korea.
Trial summary
This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea. 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/timolol
- How many people
- 756 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.
Who may be able to join
- Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- bimatoprost/timolol
- 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/timololDrug
Also called Ganfort®
Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Ganfort® | Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. Receives: Drug: bimatoprost/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Adverse Drug Reactions
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Measured: Up to 51 months
Secondary outcomes (1)
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startAug 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976624
- Sponsor's protocol ID
- 192024-087
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2013
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea
- ClinicalTrials.gov ID
- NCT01976624
- Acronym / sponsor ID
- 192024-087
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 21 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganfort® | – | Drug: bimatoprost/timololPatients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.
Key inclusion criteria (1 listed)
- Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice.
Key exclusion criteria (1 listed)
- None.
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/timololAlso: Ganfort®Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. | Drug | Ganfort® |
Primary outcome
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Up to 51 months
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
1 secondary outcome
Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in South Korea.
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 1 inclusion and 1 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events and Adverse Drug Reactions (time frame: Up to 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.