Glaucoma, Open-AnglePhase 4NCT01594970
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
A Phase 4 study testing Bimatoprost 0.01% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in South Korea.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Bimatoprost 0.01%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Bimatoprost 0.01%
- 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 0.01%Drug
Also called LUMIGAN® 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. Receives: Drug: Bimatoprost 0.01% |
| Bimatoprost 0.01% (Switched Monotherapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. Receives: Drug: Bimatoprost 0.01% |
| Bimatoprost 0.01% (with Adjunctive Therapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. Receives: Drug: Bimatoprost 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
Measured: Week 12
Secondary outcomes (2)
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Week 6, Week 12
Overall Percent Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
Measured: Baseline, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 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
- NCT01594970
- Sponsor's protocol ID
- APMA-001211
- Status last verified
- Jan 2014
- First submitted
- 8 May 2012
- Last updated
- 28 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.
PubMed 25519810
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
- ClinicalTrials.gov ID
- NCT01594970
- Acronym / sponsor ID
- APMA-001211
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 28 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Experimental | Drug: Bimatoprost 0.01%1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. |
| Bimatoprost 0.01% (Switched Monotherapy) | Experimental | Drug: Bimatoprost 0.01%1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. |
| Bimatoprost 0.01% (with Adjunctive Therapy) | Experimental | Drug: Bimatoprost 0.01%1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
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 0.01%Also: LUMIGAN® 0.01%1 drop in the affected eye(s), administered in the evening for 12 weeks. | Drug | Bimatoprost 0.01% (Naive Monotherapy), Bimatoprost 0.01% (Switched Monotherapy), Bimatoprost 0.01% (with Adjunctive Therapy) |
Primary outcome
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Time frame: Week 12
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
2 secondary outcomes
Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, Week 6, Week 12
Overall Percent Change From Baseline in IOP
Time frame: Baseline, Week 6, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25519810Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160.
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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?
A Phase 4 study testing Bimatoprost 0.01% in people with 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 Jan 2014. 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.
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?
Yes. Results are posted in the registry (first posted 28 Jan 2014). 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?
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale (time frame: Week 12). 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 NCT01594970, 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 28 Jan 2014.