Glaucoma, Open-AnglePhase 4LOTUSDINCT02020512
A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
A Phase 4 study testing 0.03% Bimatoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in China.
Trial summary
This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- 0.03% Bimatoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of open-angle glaucoma or ocular hypertension
- No use of Lumigan® in the past 3 months
Who cannot join
- Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- 0.03% Bimatoprost
- 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.
0.03% BimatoprostDrug
Also called LUMIGAN®
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0.03% Bimatoprost | Experimental | 0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks. Receives: Drug: 0.03% Bimatoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Measured: Baseline, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT02020512
- Sponsor's protocol ID
- CN-BIM-1102
- Acronym
- LOTUSDI
- Status last verified
- Jun 2014
- First submitted
- 19 Dec 2013
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02020512
- Acronym / sponsor ID
- LOTUSDI / CN-BIM-1102
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Posted 21 Jul 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 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.03% Bimatoprost | Experimental | Drug: 0.03% Bimatoprost0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of open-angle glaucoma or ocular hypertension
- No use of Lumigan® in the past 3 months
Key exclusion criteria (1 listed)
- Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
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 |
|---|---|---|
| 0.03% BimatoprostAlso: LUMIGAN®0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks. | Drug | 0.03% Bimatoprost |
Primary outcome
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline, Week 5
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- 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?
A Phase 4 study testing 0.03% Bimatoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site 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 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 21 Jul 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 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?
Yes. Results are posted in the registry (first posted 21 Jul 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?
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye (time frame: Baseline, Week 5). 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 21 Jul 2014.